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Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study

Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study (The INSPIRO Study)

NCT06272201•USGI Medical

Summary

This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).

Detailed Description

This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (g-Cath EZ Snowshoe Suture Anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).

Eligibility

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated informed consent form.
•2. Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
•3. Subjects between the ages of 22-65 years.
•4. History or failure with non-surgical weight-loss methods.
•5. If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
•6. Have a Body Mass Index (BMI) of ≥ 30 and ≤ 50 kg/m².
•7. Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
•8. Agrees to forego any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
•9. Have not taken any prescription or over-the-counter weight loss medications in the last 6 months, with exception of medications used to manage T2D so long as the subject has been on a stable dose and weight has persisted.
•10. Residing within a reasonable distance from the Investigator's treating office (\~50 miles) and willing and able to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria

•1. History of or intra-operative evidence of prior bariatric, gastric or esophageal surgery.
•2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
•3. Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
•4. Large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.
•5. Pancreatic insufficiency/disease.
•6. History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
•7. Patients who are known to be pregnant or breast-feeding, or plan to become pregnant in the next 12 months.
•8. History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
•9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
•10. Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
+18 more criteria

Key Dates

Start Date

November 1, 2024

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

February 22, 2024

Enrollment

186

ESTIMATED participants

Conditions

Obesity

Interventions

POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors

DEVICE

Contacts

VP of Medical Affairs

CONTACT

949-369-3890 info@usgimedical.com

Director, RA/QA

CONTACT

949-369-3890 tpalmer@usgimedical.com

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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: February 22, 2024Data 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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Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study

Inclusion Criteria

Exclusion Criteria

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