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Incisionless Suture Plications in a POSE2.0 Obesity Study

NCT06272201 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-04-07

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • USGI Medical

    lead INDUSTRY

Principal Investigators

  • Barham Abu Dayyeh, MD, MPH · Mayo Clinic

  • Erik Wilson, MD · University of Texas Medical School at Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-10-31
Completion
2028-11-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06272201 on ClinicalTrials.gov