Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band

Completed · Phase 4

Conditions studied: Morbid Obesity

In brief

The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.

Key facts

Study ID

NCT00543140

Run by

Ethicon Endo-Surgery

People needed

303

Starts

2006-08-01

Expected to finish

2015-01-01

Last updated by the study team

2016-03-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Surgical Associates of La Jolla Medical Group, Inc. — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Advanced Surgical Institute at Mercy Hospital — Miami, Florida, United States
• Robert T. Marema, MD — Saint Augustine, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Hamilton Medical Center - Weight Management — Dalton, Georgia, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• dgd Research, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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