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The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.
SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | All subjects enrolled will be implanted with an IGS system. The active group are those randomized to "on" and will receive active stimulation for 12 months. |
|
| B | Placebo Comparator | All subjects enrolled will be implanted with an IGS system. The placebo group are those randomized to "off" and will receive no stimulation for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcend II Model 8848 | Device | All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent excess weight loss (%EWL) from baseline after 12 months from randomization. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent excess weight loss (% EWL) from baseline at each study visit | Baseline and each study visit | |
| Change from baseline in levels of satiety and appetite at each study visit. | Baseline and each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Obesity Study Team Obesity Study Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Medtronic for specific site information | Washington D.C. | District of Columbia | 20037 | United States | ||
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Percentage change in body weight and BMI from baseline at each study visit | Baseline and each study visit |
| Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization | Baseline and 12 months. |
| Proportion of subjects who lose ≥ 5% in body weight from baseline through Month 9, and maintain the weight loss for at least 3 months (i.e., through 12 months from randomization) | Baseline and each study visit. |
| Time to loss of weight maintenance or "relapse of weight loss" | Baseline and each study visit |
| Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments | During the course of the study until termination. |
| Contact Medtronic for specfici site information |
| Gainsville |
| Florida |
| 32611 |
| United States |
| Contact Medtronic for specific site information | Chicago | Illinois | 60611 | United States |
| Contact Medtronic for specific site information | Boston | Massachusetts | 02111 | United States |
| Contact Medtronic for specific site information | Minneapolis | Minnesota | 55416 | United States |
| Contact Medtronic for specific site information | St Louis | Missouri | 60611 | United States |
| Contact Medtronic for specific site information | New York | New York | 10032 | United States |
| Contact Medtronic for specific site information | Philadelphia | Pennsylvania | 19140 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |