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Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Placement | Experimental | The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self Forming Magnetic (SFM) Anastomosis System | Device | The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Weight loss measured as a percent of total body weight (TBW) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Responders | Percent responders; i.e. percent of subjects losing at least 10% TBW | 12 months |
| Excess Weight Loss Measures | Excess weight loss (EWL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada | ||
| Université Laval |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 12 months |
| Absolute Weight Loss Measures | Absolute weight loss | 12 months |
| BMI - Weight Loss Measures | Change in BMI | 12 months |
| Fasting Glucose | Mean change in fasting glucose | 12 months |
| Hemoglobin A1c | Mean change in Hemoglobin A1c | 12 months |
| Diabetes Remission and/or Improvements | Proportion of subjects experiencing diabetes remission and/or improvements | 12 months |
| Diabetes Medication Dosage and Frequency Changes | Mean change in the dosage and frequency of diabetes medications from baseline | 12 months |
| Serum Lipids | Mean change in serum lipids | 12 months |
| Blood Pressure Changes | Mean percent change in systolic/diastolic blood pressure | 12 months |
| Liver Changes using Fibroscan | Change in Controlled Attenuation Parameter (CAP) Scores from baseline | 12 months |
| Nutritional Status | Nutritional Status: changes in pre-albumin levels | 12 months |
| Albumin - Nutritional Status | Nutritional Status: changes in albumin levels | 12 months |
| Québec |
| Quebec |
| G1V 4G5 |
| Canada |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |