Actively Recruiting
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
Led by University Hospital, Grenoble · Updated on 2025-03-14
200
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Grenoble
Lead Sponsor
E
Endo Tools Therapeutics S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18-65 years
- Recently diagnosed Type 2 Diabetes (10 years or less)
- HbA1c less than 9%
- Currently on stable non-insulin anti-diabetic treatment (e.g., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i) alone or in combination
- Anti-diabetic therapy stable for the last 3 months before inclusion
- Body mass index (BMI) between 30 and 34.9 kg/m8 (adjusted to 27.5-32.5 kg/m8 for Asian population)
- Ability to comply with all study requirements including treatment, dietary follow-up, visit schedules, and study procedures
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Contraindication to use of Endomina4 and TAPES devices according to their instructions for use
- Type 1 diabetes defined by C peptide less than 0.2 nmol/l or presence of specific antibodies (anti-GAD, anti IA2, anti-ZNT8)
- Unstable diabetic retinopathy
- Severe kidney disease (stage 4-5), severe liver disease (Child B and C cirrhosis), severe lung disease, or cancer diagnosed in the past 5 years
- Short-term prognosis with serious comorbidity including severe macrovascular complications or life expectancy less than 5 years
- Contraindication to endoscopic gastroplasty
- Planned gastric surgery within 60 days after intervention
- Participation in another interventional clinical study
- Alcohol or drug addiction
- Severe mental illnesses such as psychosis, bipolar disorder, severe current depression, or eating disorders like bulimia nervosa or binge eating disorder
- Being deprived of liberty by judicial order
- Under guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chu Grenoble Alpes
La Tronche, France, 38043
Actively Recruiting
Research Team
L
L. LECLERCQ, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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