Clinical trial NCT00200083: Study of Weight Loss Using Gastric Stimulation in Obese Patients
Official title: SHAPE: Screened Health Assessment & Pacer Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Morbid Obesity
Keywords: Obesity
Morbid Obesity
SHAPE
IGS
Implantable Gastric Stimulator
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Percent excess weight loss (% EWL) from baseline at each study visit
timeFrame: Baseline and each study visit
measure: Change from baseline in levels of satiety and appetite at each study visit.
timeFrame: Baseline and each study visit
measure: Percentage change in body weight and BMI from baseline at each study visit
timeFrame: Baseline and each study visit
measure: Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization
timeFrame: Baseline and 12 months.
measure: 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)
timeFrame: Baseline and each study visit.
measure: Time to loss of weight maintenance or "relapse of weight loss"
timeFrame: Baseline and each study visit
measure: Incidence of adverse events, Incidence of device complications, Change in blood chemistry and hematology laboratory assessments
timeFrame: During the course of the study until termination.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Contact Medtronic for specific site information
state: District of Columbia
city: Gainsville
country: United States
facility: Contact Medtronic for specfici site information
state: Florida
city: Chicago
country: United States
facility: Contact Medtronic for specific site information
state: Illinois
city: Boston
country: United States
facility: Contact Medtronic for specific site information
state: Massachusetts
city: Minneapolis
country: United States
facility: Contact Medtronic for specific site information
state: Minnesota
city: St. Louis
country: United States
facility: Contact Medtronic for specific site information
state: Missouri
city: New York
country: United States
facility: Contact Medtronic for specific site information
state: New York
city: Philadelphia
country: United States
facility: Contact Medtronic for specific site information
state: Pennsylvania
Study officials:
affiliation: Medtronic
name: Obesity Study Team Obesity Study Team
role: STUDY_CHAIR
References: