NCT00166205

Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
DEVICE	Swedish Adjustable Gastric Band	Long term implantable device.

Timeline

• Start date: 2003-06-01
• Completion: 2006-12-01
• First posted: 2005-09-14
• Last updated: 2015-09-01
• Results posted: 2008-12-11

Locations

12 sites across 1 country: United States