Incisionless Suture Plications in a POSE2.0 Obesity Study

Sponsor
USGI Medical
Study ID
NCT06272201
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Feb 22, 2024
Start date
Oct 31, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    POSE2.0 Treatment with Lifestyle Modification
  • No Intervention: Control
    Lifestyle Modification alone

Primary Outcome Measure

Percentage of total body weight loss (%TBWL) following randomization [ Time Frame: 12 months ]

Central Contacts

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