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Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
Single-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 for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFM Treatment Arm | Experimental | The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion |
|
| 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 metabolic disease indicators |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | 1. Weight loss measured as a percent of total body weight (TBW) | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent responders | Percent of subjects losing at least 10% and 20% of baseline weight from baseline | 12 Months |
| Excess weight loss | Mean change in Excess weight loss from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Turro, MD | Gastroenterologist at Teknon Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Teknon | Barcelona | Spain |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 12 Months |
| Change in serum lipids | Mean change in serum lipids from baseline | 12 Months |
| Change in blood pressure | Mean change in blood pressure from baseline | 12 Months |
| Change in fasting glucose | Mean change in fasting glucose in subjects with T2DM at baseline | 12 Months |
| Change in HbA1c | Mean change in HbA1c in subjects with T2DM at baseline | 12 Months |
| Change in BMI | Mean change in BMI from baseline | 12 Months |
| Change in Absolute Weight Loss | Mean change in Absolute Weight Loss from baseline | 12 Months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |