Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00166205
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
Sponsor:
Ethicon Endo-Surgery
Organization:
Study Overview
Official Title:
A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
Status:
COMPLETED
Status Verified Date:
2015-08
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:
None
Brief Summary:
The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB) is safe, and effective in achieving weight loss in patients with Morbid Obesity.
Detailed Description:
Surgical treatment of morbidly obese patients is considered a reasonable option for achieving weight loss when more conservative measures, such as diet and exercise have failed. Not only can weight loss be achieved, but also reduction / resolution of a patient's co-morbidities associated with excess weight. Adjustable gastric banding provides a less invasive, reversible bariatric surgery option. The SAGB has been commercially available outside the United States for this indication since 1996. Commercial availability has led to extensive literature supporting the safety and effectiveness of the SAGB. Given the available literature, a prospective, single arm, multicenter, study in a heterogeneous population of morbidly obese subjects in the U.S. is being conducted.
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?: