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

NCT ID: NCT05516576

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-29
• Study Completion Date: 2028-12-31

Brief 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

Diabetes Mellitus, Type 2; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endoscopic gastroplasty with endomina®

Group Type: EXPERIMENTAL

endomina®

Intervention Type: DEVICE

Endoscopic gastroplasty

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

endomina®

Endoscopic gastroplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 18-65 years;
• Recently diagnosed Type 2 Diabetes (<= 10 years):
• HbA1c < 9%:
• Under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i, alone or in combination
• Anti-diabetic therapy stable during the last 3 months before inclusion
• BMI between 30-34.9 kg/m² with adaptation for Asian population 27.5-32.5kg/m²
• Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to randomization treatment, dietary follow up, visits schedule and all study specific procedures);
• Must be able to understand and be willing to provide written informed consent.

Exclusion Criteria

• Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU).
• Type I diabetes characterized by C peptide <0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8
• Unstable diabetic retinopathy
• Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years);
• Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (<5 years)
• Contra-indication to endoscopic gastroplasty (...)
• Impending gastric surgery 60 days post intervention;
• Participant involved in another interventional clinical study
• Patients having alcoholic or drug addiction;
• Patients having a severe mental illness such as psychosis, bipolar disorders, severe, current depression or eating disorder such as bulimia nervosa or binge eating disorder;
• Person deprived of liberty by judicial order
• Person under guardianship or curatorship

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Tools Therapeutics S.A.

INDUSTRY

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

A-L BOREL, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University Grenoble Hospital

Locations

Chu Grenoble Alpes

La Tronche, , France

Site Status: RECRUITING

Countries

France

Central Contacts

L. LECLERCQ, MSc

Role: CONTACT

ESTIME@endotools.be

+3271919409

Facility Contacts

Anne-Laure BOREL, MDD

Role: primary

ALBorel@chu-grenoble.fr

Other Identifiers

ST-2019-002

Identifier Type: -

Identifier Source: org_study_id