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The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults.
The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by side- anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno- ileostomy (SADI) procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAGNET System, DI Biofragmentable | Experimental | GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAGNET System, DI Biofragmentable | Device | Anastomoses achieved by magnetic compression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnet Placement | MagGJ System placement ≥ 90% alignment of magnets | 1 Day (during study index procedure) |
| Natural Magnet Passage | Passage of magnets without surgical re-intervention | Index Procedure through 90 days |
| Anastomosis Patency | Confirmed radiologically | Index Procedure through 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporativo Hospital Satelite | Naucalpan | Mexico |
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This is an open-label, multicenter study enrolling up to 25 subjects at up to 3 study centers in Mexico
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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