Trials / Unknown
UnknownNCT03837691
A Feasibility Study for the Treatment of Primary Obesity
A Feasibility Study Examining Safety and Preliminary Effectiveness of a Procedural Technique Using an Endoscopic Suturing Device and Associated Devices for the Treatment of Primary Obesity
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- USGI Medical · Industry
- Sex
- All
- Age
- 22 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This study has been expanded to a four center, open-label, 2-group randomized pilot study evaluating a treatment for obesity.
Detailed description
This study has been expanded to a four center, open-label, 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, Pose 2 (sutures placed in the mid + distal body without 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). Efficacy will be evaluated based on changes in weight loss for all subjects through 12 months. Adverse events will be recorded throughout the duration of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Placement of Snowshoe Suture Anchors | Snowshoe suture anchors from g-Cath EZ Delivery Catheters are placed in the stomach with the aid of a Transport, g-Lix and g-Prox device |
| BEHAVIORAL | Moderate Intensity Diet & Exercise Program | After placement of the snowshoe suture anchors in the stomach, subjects are asked to follow a moderate intensity diet and exercise program |
Timeline
- Start date
- 2019-10-10
- Primary completion
- 2023-06-15
- Completion
- 2023-10-15
- First posted
- 2019-02-12
- Last updated
- 2023-05-19
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03837691. Inclusion in this directory is not an endorsement.