Study of Weight Loss Using Gastric Stimulation in Obese Patients (SHAPE)

Medtronic

Status: Completed

Conditions: Obesity; Morbid Obesity

Treatments: Device: Transcend II Model 8848

Study type: Interventional

Funder types: Industry

Identifiers

NCT00200083

95-2002-015

Details and patient eligibility

About

The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

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.

Treatment:

Device: Transcend II Model 8848

B

Placebo Comparator group

Description:

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.

Treatment:

Device: Transcend II Model 8848