Diabetes Mellitus, Type 2ESTIMENCT05516576
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
A study testing endomina® in people with Diabetes Mellitus, Type 2 and Obesity, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- endomina®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 (...)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
La Tronche, 38043
Anne-Laure BOREL, MDD, ALBorel@chu-grenoble.fr
About this study
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
- Being tested
- endomina®
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endomina®Device
Endoscopic gastroplasty
| Study group | Role | What they receive |
|---|---|---|
| endoscopic gastroplasty with endomina® | Experimental | Not described Receives: Device: endomina® |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity
Remission is defined as HbA1c < 6.5% without antidiabetic drug for at least 3 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start29 Sep 2023
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Endo Tools Therapeutics S.A.
- Responsible party
- Sponsor
- Investigators
- A-L BOREL, MD PHD, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516576
- Sponsor's protocol ID
- ST-2019-002
- Acronym
- ESTIME
- Status last verified
- Dec 2024
- First submitted
- 15 Jul 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05516576
- Acronym / sponsor ID
- ESTIME / ST-2019-002
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Endo Tools Therapeutics S.A.
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic gastroplasty with endomina® | Experimental | Device: endomina® |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endomina®Endoscopic gastroplasty | Device | endoscopic gastroplasty with endomina® |
Primary outcome
Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity
Time frame: 24 months
Remission is defined as HbA1c < 6.5% without antidiabetic drug for at least 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A-L BOREL, MD PHD principal investigator
University Grenoble Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endomina® in people with Diabetes Mellitus, Type 2 and Obesity, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact L. LECLERCQ, MSc (+3271919409, ESTIME@endotools.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.