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The purpose of the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients.
This is a single center open label feasibility study to evaluate the safety, efficacy and performance of the ValenTx Endo Bypass system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ValenTx Endo Bypass System | Device | Patient is implanted with device and followed for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse events | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device performance | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Rumbaut, MD | Hospital San Jose Tec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Jose Tec de Monterrey | Monterrey | 64710 | Mexico |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |