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| Name | Class |
|---|---|
| Endo Tools Therapeutics S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic gastroplasty with endomina® | Experimental |
| |
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endomina® | Device | Endoscopic gastroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| L. LECLERCQ, MSc | Contact | +3271919409 | ESTIME@endotools.be |
| Name | Affiliation | Role |
|---|---|---|
| A-L BOREL, MD PHD | University Grenoble Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble Alpes | Recruiting | La Tronche | 38043 | France |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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