Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166205
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2005-09-09
Brief Title:
Safety and Effectiveness Study of The Swedish Adjustable Gastric Band SAGB in the Treatment of Morbid Obesity
Sponsor:
Ethicon Endo-Surgery
Organization:
Ethicon Endo-Surgery
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 patients 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 US is being conducted
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