Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200083
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2005-09-12
Brief Title:
Study of Weight Loss Using Gastric Stimulation in Obese Patients
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
SHAPE Screened Health Assessment Pacer Evaluation
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHAPE
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 kgm2
SHAPE was a randomized placebo-controlled double-blind multi-center pivotal study in which all subjects were implanted with the IGS system
SHAPE was a randomized placebo-controlled double-blind multi-center pivotal study in which all subjects were implanted with the IGS system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None