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RT-310 Dose Escalation BPH Study | Clinical Trials | Clareo Health

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RT-310 Dose Escalation BPH Study

Safety and Feasibility Dose Escalation Study for Evaluation of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

NCT06136819•Resurge Therapeutics Inc.

View on ClinicalTrials.gov

Summary

RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

Detailed Description

The RT-310 study is a first in human Phase 1 multi-center prospective, non-randomized dose escalation study to evaluate the safety and feasibility of RT-310 for treatment of Benign Prostatic Hyperplasia (BPH). Study participants will have placement of RT-310 and be followed through 180 days.

Eligibility

Age

50 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male gender
•Diagnosis of symptomatic BPH
•Age ≥ 50 years up to 80 years
•International Prostate Symptom Score (IPSS) ≥ 13
•Prostate volume 30 to 80 cc per ultrasound
•Inadequate response and/or refusal of medical therapy for LUTS

Exclusion Criteria

•Current urinary retention or at significant risk of urinary retention after drug washout
•Have an obstructive or protruding median lobe of the prostate
•Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
•Previous pelvic surgery or irradiation
•History of neurogenic or atonic bladder
•Stress urinary incontinence, mixed or urge incontinence
•History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
•History of compromised renal function or upper urinary tract disease
•Other co-morbidities that could impact the study results such as: severe cardiac arrhythmias uncontrolled by medications or pacemaker; congestive heart failure New York Heart Association (NYHA) III or IV; History of uncontrolled diabetes mellitus; significant respiratory disease in which hospitalization may be required
•Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
+7 more criteria

Locations (4)

Australian Clinical Trials

Wahroonga, New South Wales, Australia

Goldfields Urology

Bendigo, Victoria, Australia

Western Urology

Maribyrnong, Victoria, Australia

Tauranga Urology Research

Tauranga, North Island, New Zealand

Key Dates

Start Date

April 19, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2027

Last Updated

November 28, 2025

Enrollment

ESTIMATED participants

Conditions

BPH (Benign Prostatic Hyperplasia)Lower Urinary Tract Symptoms

Interventions

RT-310

COMBINATION_PRODUCT

RCT on Running Water Sound During Urodynamic

NCT07451548

Lower Urinary Tract Symptoms (LUTS)

View study

RECRUITINGNA

HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

NCT03802851

Prostate CancerLower Urinary Tract Symptoms

View study

RECRUITINGNA

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RT-310 Dose Escalation BPH Study

Inclusion Criteria

Exclusion Criteria

RCT on Running Water Sound During Urodynamic

HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

PRescription Exercise for Older Men With Urinary Disease

JING SI HERBAL TEA and Urinary Tract Symptoms in Bladder Cancer

Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes