NCT06272201

Incisionless Suture Plications in a POSE2.0 Obesity Study

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: USGI Medical · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-10-01
• Primary completion: 2028-10-01
• Completion: 2028-11-01
• First posted: 2024-02-22
• Last updated: 2026-04-07

Regulatory

• FDA-regulated device study