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RECRUITING
NCT05516576
NA
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
Sponsor: University Hospital, Grenoble
View on ClinicalTrials.gov
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-09-29
Completion Date
2028-12
Last Updated
2025-03-14
Healthy Volunteers
No
Conditions
Interventions
DEVICE
endomina®
Endoscopic gastroplasty
Locations (1)
Chu Grenoble Alpes
La Tronche, France