Trials / Recruiting
RecruitingNCT05516576
Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | endomina® | Endoscopic gastroplasty |
Timeline
- Start date
- 2023-09-29
- Primary completion
- 2028-11-01
- Completion
- 2028-12-01
- First posted
- 2022-08-25
- Last updated
- 2025-03-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05516576. Inclusion in this directory is not an endorsement.