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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

NCT05516576 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-03-14

No results posted yet for this study

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

Interventions

DEVICE

endomina®

Endoscopic gastroplasty

Sponsors & Collaborators

  • Endo Tools Therapeutics S.A.

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • A-L BOREL, MD PHD · University Grenoble Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516576 on ClinicalTrials.gov