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NCT07161024
This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate. Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system. Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition. The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees. The investigators will also implement the NASA-task load index for the trainees to gauge the usability of the system.
NCT07514351
Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other
NCT07155005
The goal of this clinical trial is to evaluate the effectiveness and safety of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System versus other commonly used renal-stone interventions.
NCT07465367
Some kidney stones including calcium phosphate and struvite stones form in vary alkaline urine (high pH). Currently available medication for stone prevention, namely citrate supplementation, can lead to even higher pH levels and promote stone formation. Multiple prior studies have looked at ways to acidify the urine to reduce the risk of recurrent stone formation. Ascorbic acid has been evaluated but showed no reduction in urinary pH. Ammonium chloride has shown to be effective but poorly tolerated (GI upset) at higher doses and thus is not recommended. Most recently, citric acid has been investigated but demonstrated no change in pH as compared to placebo. L-methionine is an amino acid which is metabolized to sulfate and hydrogen ions by the liver, thereby conferring an acid load onto the kidney and in theory can reduce the pH. Prior studies have demonstrated effective acidification of the urine in healthy individuals and amongst struvite stone formers. The purpose of this study is to assess the ability of L-methionine to acidify the urine of calcium phosphate stone formers. The study will involved patients abiding by a short term metabolic diet. The diet consists of typical foods (some frozen, some fresh) that have been carefully balanced to match the recommended/optimal amount of calories, protein, fat, sodium and calcium for a specific body weight. After eating this diet for 2 days, patients will begin taking L-methionine. The metabolic diet will then be resumed for 2 days at the end of taking the L-methionine (both taken together). At various times of the study, urine collections will be performed to see whether the urine becomes more acidic as a result of the L-methionine. If applicable, participants will be asked to undergo drug washout, to begin after consenting. If participants are taking Thiazide diuretics including hydrochlorothiazide, Chlorthalidone, and indapamide and alkali medications including potassium citrate, sodium bicarbonate, sodium citrate, and potassium bicarbonate, they will be asked to stop taking them 5 days before Day 1 of the protocol.
NCT07389226
This is a single-center prospective cohort study to evaluate the effect of short-term daily apple cider vinegar (ACV) supplementation on urine chemistry.
NCT07359391
Here is a \*\*patient-friendly, ClinicalTrials.gov-compliant Brief Summary\*\* written in \*\*plain language\*\*, avoiding technical jargon as much as possible while remaining accurate. You can \*\*copy-paste this directly\*\* into the \*\*Brief Summary\*\* field. * \*\*Brief Summary\*\* Percutaneous nephrolithotomy (PCNL) is a common surgical procedure used to remove large kidney stones. Patients often experience moderate to severe pain after this surgery due to the surgical incision and irritation of the kidney and surrounding tissues. Effective pain control after PCNL is important to improve patient comfort, reduce the need for opioid medications, and enhance recovery. Several regional anesthesia techniques have been developed to reduce postoperative pain. Two of these techniques are the dual-approach external oblique fascial plane block and the erector spinae plane block. Both techniques involve injecting a local anesthetic near specific muscle planes using ultrasound guidance to reduce pain signals from the surgical area. However, it is not yet clear which of these two techniques provides better pain relief after PCNL. This study aims to compare the effectiveness of the dual-approach external oblique fascial plane block and the erector spinae plane block in controlling pain after PCNL surgery. Adult patients scheduled for PCNL will be randomly assigned to receive one of the two nerve block techniques or standard general anesthesia alone. Pain levels, additional pain medication requirements, patient satisfaction, and any block-related complications will be assessed during the first 24 hours after surgery. The results of this study may help determine the most effective regional anesthesia technique for improving postoperative pain management in patients undergoing PCNL.
NCT07336485
This randomized controlled clinical trial evaluated whether furosemide-assisted forced diuresis during flexible ureteroscopy reduced the residual fragment rate and improved the stone-free rate after flexible ureteroscopy for management of medium sized renal stones measuring up to 30 millimeters. Adult patients undergoing flexible ureteroscopy for renal stones were randomized into two parallel groups: an experimental group that received intravenous furosemide during the procedure and a control group that received standard perioperative and postoperative care without furosemide. Stone-free status and residual fragments were assessed using non-contrast computed tomography performed four weeks after the procedure, and residual fragments were classified by fragment size. Secondary outcomes included operative time, length of hospital stay, postoperative complications, total urine output in the first 24 hours, and the need for additional treatments for significant residual stones.
NCT07055282
This study is looking at whether empagliflozin, a medication typically used for diabetes and heart conditions, may affect factors that contribute to kidney stone formation. The research focuses on people who have had calcium-based kidney stones, i.e. calcium oxalate or calcium phosphate stones. Previous studies in those without kidney stones found that empagliflozin increased urinary citrate levels without raising urine pH. The investigators are testing whether similar effects occur in people with a history of kidney stones. Participants will take empagliflozin daily for 4 weeks. The investigators will collect 24-hour urine samples before and after treatment to measure various factors that influence stone formation, including citrate levels, pH, and calculated stone formation risk. The investigators will enroll 32 participants: 16 with a history of calcium oxalate stones and 16 with calcium phosphate stones. Results from this study may inform future larger clinical trials investigating empagliflozin as a kidney stone prevention strategy.
NCT07296835
Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS devices in RIRS are lacking in an American population. The investigators aim to compare the outcomes of using the 6.3 Fr f-URS versus traditional approach (other f-URS present in our institution) to treat patients with stone burden ≤ 2.5 cm. The findings of this study will expand on the potential advantages and drawbacks of HU30M in enhancing surgical outcomes and patient safety in RIRS procedures. We hypothesize that the use of the HU30M will result in increased cost savings while providing similar stone free rates when compared to traditionally used f-URS devices.
NCT07174479
This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate. Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system. Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition. The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees. The investigators will also implement the NASA-task load index for the trainees to gauge the usability of the system.
NCT07173309
This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate. Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system. Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition. The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees. The investigators will also implement the NASA-task load index for the trainees to gauge the usability of the system.
NCT07211555
This study is being done to evaluate a new robotic system that helps urologists more precisely reach the kidney during surgery to remove large kidney stones. The procedure, called percutaneous nephrolithotomy (PCNL), is typically used for people who have large or difficult-to-remove kidney stones. Traditionally, many urologists rely on radiologists to place a tube into the kidney before surgery. This can cause delays, require multiple procedures, and increase costs. The robotic system being studied - called LARC - is designed to help the urologist safely and accurately guide a needle directly into the kidney during the surgery, without needing a separate procedure beforehand. The robot uses live X-ray images to help align the instruments. Although parts of the robot have been approved by the U.S. FDA, the version used in this study is still investigational and not yet approved for this specific purpose. The study will take place at AdventHealth Celebration and include up to 45 adult patients who are scheduled for PCNL surgery. Participants will be followed for up to 1 month after surgery, and doctors will look at outcomes such as the success of the procedure, the number of kidney stones removed, complications, time in surgery, and radiation exposure. This research may help make kidney stone surgery safer, faster, and more effective in the future.
NCT07101809
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
NCT07159503
The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL). The main questions it aims to answer are: How many participants are stone-free within 24 hours after surgery? How many participants are stone-free 1 month after surgery? What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL? Does VISOR help keep kidney pressure stable during surgery? Researchers will compare VISOR to PCNL to see which treatment works better and is safer. Participants will: Be randomly assigned to have surgery with either VISOR or PCNL. Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared. Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging. About 170 people will take part in this study at cooperative hospitals.
NCT06987084
The aim of this randomized placebo-controlled double-blind crossover clinical trial is to test the ability of a traditional tea made from the leaf of the Bryophyllum pinnatum (B. pinnatum) plant in decreasing urinary calcium content in patients with recurrent calcium-based kidney stones.
NCT06898216
This multicenter, randomized, controlled superiority trial (the SCULPT trial) aims to compare the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) versus the conventional FANS in the treatment of lower pole renal stones ≤2 cm. Lower pole stones are particularly challenging due to the narrow infundibular-pelvic anatomy that limits the maneuverability of standard FANS. The steerable FANS incorporates an active deflection mechanism that allows for independent control, potentially improving the success rate of accessing the lower pole calyx, performing laser lithotripsy, and aspirating stone fragments without additional adjuncts. A total of 400 patients from 20 high-volume urological centers in China (approximately 20 patients per center) will be randomized in a 1:1 ratio to receive either steerable FANS or conventional FANS during flexible ureteroscopy. Primary outcome measures include the success rate of FANS navigation into the lower pole calyx as evidenced by direct stone visualization, effective laser lithotripsy, and successful stone aspiration. Secondary outcomes will assess immediate and 1-month stone-free rates, operative time, complication rates, instrument durability, and improvements in quality of life. This study is expected to provide critical evidence to guide clinical decision-making and potentially improve treatment efficiency for challenging lower pole renal stones.
NCT06746779
This study investigates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (RIRS) in patients with kidney stones. A retrospective analysis was conducted on 234 patients who underwent RIRS, evaluating factors such as preoperative ureteral diameters (measured at distal, iliac, and upper ureteral levels via CT scans), stone size, patient demographics, operation duration, and surgical success rates. The findings aim to determine whether ureteral diameter measurements can serve as reliable predictors for surgical challenges, ultimately improving preoperative planning and patient outcomes.
NCT02831556
Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.
NCT06124066
Double J stent (ureteral stent) can cause discomfort to patients, generally due to irritation of the bladder mucosa, especially in the trigone area, smooth muscle spasm, and reflux of urine into the ureter. Complaints often appear in patients, especially lower urinary tract symptoms (LUTS), pain in the waist when urinating due to reflux of urine, sexual dysfunction, and hematuria. Currently, to assess complaints after ureteral stent placement, the Ureteral Stent Symptom Questionnaire instrument consists of 6 topics: urinary complaints, pain, general health, work, sexual problems, and other things. Interleukin-6 is an important inflammatory cytokine when irritation occurs after ureteral stent placement. Interleukin 10 is a cytokine with potent anti-inflammatory properties that plays a central role in limiting the host's immune response to pathogens, thereby preventing host damage and maintaining normal tissue homeostasis. The profile of these biomarkers has the potential to determine the correct prognosis and therapy. Mirabegron is a β3 adrenergic receptor agonist that has a dual antioxidant effect that plays a key role in the first step of the antimicrobial response and early resolution of inflammation so that post-stent complaints similar to overactive bladder complaints can be resolved. Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter, thereby reducing the inflammatory reaction and improving oxidative stress by reducing the formation of reactive oxidative stress.
NCT02188108
The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are: 1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing the HRQOL of patients who form kidney stones from a broad region of North America?" 2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes within individuals?"