Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band - Full Text View

Sponsored by:	Ethicon Endo-Surgery
Information provided by:	Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00543140

Purpose

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. This trial is a continuation of a 3-year study and will follow subjects with a SAGB band in place for an additional 2 years.

Condition	Intervention	Phase
Morbid Obesity	Device: Swedish Adjustable Gastric Band	Phase III

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Post Implantation/Post Market Evaluation of Safety and Quality of Life in Subjects Implanted With the Swedish Adjustable Gastric Band (SAGB) During Protocol CI-02-0006

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:

To determine the rate of device-related adverse events (AEs) and malfunctions 4 and 5 years post implant. [ Time Frame: 5 years ]

Secondary Outcome Measures:

To evaluate changes in Quality of Life measures 4 and 5 years post implant. [ Time Frame: 5 years ]
To evaluate changes in Glycosylated hemoglobin (HbA1C) and serum lipid levels 4 and 5 years post implant. [ Time Frame: 5 years ]

Estimated Enrollment:	271
Study Start Date:	August 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Laparoscopic placement of the Swedish Adjustable Gastric Band

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

able to comprehend, follow and give signed informed consent
consented to, and participated in EES Protocol CI-02-0006 titled "A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity"
currently have an SAGB implant in place
able to commit to long-term follow-up; up to 5 years after SAGB implantation, including band adjustment visits
Living within the contiguous U.S.

Exclusion Criteria:

Consented to, and participated in EES Protocol CI-02-0006 titled "A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity"; and have had the SAGB explanted.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543140

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Surgical Associates of La Jolla Medical Group, Inc.
La Jolla, California, United States, 92037
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Advanced Surgical Institute at Mercy Hospital
Miami, Florida, United States, 33133
United States, Georgia
Hamilton Medical Center - Weight Management
Dalton, Georgia, United States, 30722
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025

Sponsors and Collaborators

Ethicon Endo-Surgery

Investigators

Principal Investigator:

Edward Phillips, MD

Cedars Sinai

More Information

Study ID Numbers:	CI-06-0001
Study First Received:	August 28, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00543140
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:

Obesity
Morbid Obesity

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Quality of Life

Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 15, 2009