Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedtronicNeuro
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Study of Weight Loss Using Gastric Stimulation in Obese Patients
