Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01077193
Status:
TERMINATED
Last Update Posted:
2014-02-07
First Post:
2010-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Sponsor:
Ethicon Endo-Surgery
Organization:
Study Overview
Official Title:
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to commercial considerations and potential patient attrition at 3 years. There were no patient safety or procedure efficacy reasons.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: