Morbid Obesity, Obesity
Conditions
Keywords
Obesity, Morbid Obesity, SHAPE, IGS, Implantable Gastric Stimulator
Brief summary
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
Detailed description
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.
Interventions
DEVICETranscend II Model 8848
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.
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 65 years of age at time of screening * BMI of 35 to 55 kg/m2 at time of screening * Patients with a reported history of five years of obesity (BMI \> 30 kg/m2)
Exclusion criteria
* Patients who are excluded by the screening algorithm * Patients scoring 29 or higher on the Binge Eating Scale Questionnaire * Patients taking any weight loss medication or other drugs that can affect body weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent excess weight loss (%EWL) from baseline after 12 months from randomization. | Baseline, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in levels of satiety and appetite at each study visit. | Baseline and each study visit |
| 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. |
| Percent excess weight loss (% EWL) from baseline at each study visit | 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. |
| 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. |
Countries
United States
Outcome results
None listed