NCT05939973

A Feasibility Study for the Treatment of Primary Obesity Cross-over Arm

A Feasibility Study Examining Safety and Preliminary Effectiveness of a Procedural Technique Using an Endoscopic Suturing Device (g-Cath EZ Delivery Catheter With Snowshoe Suture Anchors) and Associated Devices for the Treatment of Primary Obesity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: USGI Medical · Industry
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Cross-over arm of the pilot study evaluating a treatment for obesity.

Detailed description

This is a multi-center, open-label, cross-over arm from the 2-group randomized pilot study evaluating a treatment for obesity. The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, POSE2.0 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program. 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). Efficacy will be evaluated based on changes in weight loss through 12 months. Adverse events will be recorded throughout the duration of the study.

Conditions

• Obesity, Primary

Interventions

Type	Name	Description
DEVICE	g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors	The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, POSE2.0 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program.

Timeline

• Start date: 2023-01-19
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study