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This is a prospective, observational, case series registry which will collect information pertaining to experiences and health economics in individuals implanted with vBloc Therapy who are conjunctively using a weight management program. Subjects will be followed for 12 months after implant.
The vBloc is a neuromodulation system that consists of the following implantable and external components:
Schedule of events following the baseline study visit include: implant, 2 week follow up, and 1, 3, 6, 9, and 12 month follow up visits. Enrolled subjects will also use the vBloc Achieve weight management program, which is a remote weight management counseling sessions with a registered dietitian to discuss healthy diet and exercise habits and weight loss goals.
The vBloc Now registry, together with vBloc Therapy and the vBloc Achieve weight management program, incorporates specific diets after the implant, routine remote counseling by an experienced registered dietitian, recommendations for physical activity, and tracking of weight, food intake, and fitness. The expectation is that patients participating in the vBloc Now registry, who comply with the diet and behavioral recommendations in combination with use of the Maestro device, will see an improvement in their overall health, whether it's related to weight loss, improvements in co-morbidities, or a better quality of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vBloc Maestro Rechargeable System | Device | vBloc therapy consists of a neuromodulation device that delivers intermittent, controllable electrical blocking algorithms, to the intra-abdominal vagus nerve for the treatment of obesity. |
| Measure | Description | Time Frame |
|---|---|---|
| Real world experiences | health data pertaining to weight and obesity comorbidities | 12 months following implant |
| Health economics | Collecting data to examine quality of life and work productivity after implant | 12 months following implant |
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Inclusion criteria
Exclusion criteria
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Anyone 18 years of age and older with a BMI ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid conditions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sky Ridge | Lone Tree | Colorado | 80124 | United States | ||
| Christiana Institute of Advanced Surgery |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Newark |
| Delaware |
| 19713 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |