Trials / Completed
CompletedNCT03721731
A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity
A Post-Market Surveillance Study Examining the Safety & Effectiveness of Using the g-Cath EZ Delivery Catheter With Snowshoe Suture Anchors and Associated Devices (g-Prox EZ, g-Lix and Transport) for the Treatment of Obesity
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 39 (actual)
- Sponsor
- USGI Medical · Industry
- Sex
- All
- Age
- 22 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, prospective study evaluating a treatment for obesity.
Detailed description
This is a multi-center, prospective study evaluating a treatment for obesity using the g-Cath EZ and associated devices. The intent is to evaluate the safety and efficacy of a modified Snowshoe suture anchor placement pattern called Pose 2 (suture anchors placed in the mid + distal body of the stomach, with none placed in the fundus) along with a moderate intensity diet and exercise program. The g-Cath EZ and the associated devices (the g-Prox EZ, g-Lix \& Transport) are known collectively as the Incisionless Operating Platform (IOP). Efficacy of the treatment will be evaluated based on changes in weight loss over 12 months, \& adverse events will be recorded throughout the duration of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Obesity treatment with a Plication device | Plicating the stomach to treat obesity |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2020-02-21
- Completion
- 2020-02-21
- First posted
- 2018-10-26
- Last updated
- 2020-11-04
Locations
2 sites across 1 country: Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03721731. Inclusion in this directory is not an endorsement.