Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00166205|
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : December 11, 2008
Last Update Posted : September 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Morbid||Device: Swedish Adjustable Gastric Band||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2003|
|Actual Study Completion Date :||December 2006|
Experimental: Gastric Band
Single-arm study, all subjects banded.
Device: Swedish Adjustable Gastric Band
Long term implantable device.
Other Name: Realize Band
- Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB) [ Time Frame: 3 years ]Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.
- Percent Excess Weight Loss [ Time Frame: 3 Years Post Operative ]Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.
- Changes in Excess Body Weight (EBW) [ Time Frame: 3 years ]Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.
- Changes in Body Mass Index (BMI) [ Time Frame: 3 years ]Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.
- Change in Absolute Weight [ Time Frame: 3 years ]Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.
- Changes in Quality of Life (QOL) Measures [ Time Frame: 3 years ]Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.
- Changes in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 3 years ]Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.
- Number of All Adverse Events of Subjects Implanted With the SAGB [ Time Frame: 3 Years ]The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).
- Changes in High Density Lipoproteins (HDL) [ Time Frame: 3 year ]Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.
- Changes in Low Density Lipoproteins (LDL) [ Time Frame: 3 years ]Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.
- Changes in Total Cholesterol [ Time Frame: 3 years ]Changes in Total Cholesterol, at three-years post-operative minus baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166205
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Scripps Clinic Medical Group|
|San Diego, California, United States, 92130|
|United States, Florida|
|Ft. Lauderdale, Florida, United States, 33308|
|Advanced Surgical Institute at Mercy Hospital|
|Miami, Florida, United States, 33133|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|United States, Georgia|
|Hamilton Medical Center - Weight Management|
|Dalton, Georgia, United States, 30720|
|United States, Louisiana|
|Weight Management Center|
|New Orleans, Louisiana, United States, 70115|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|United States, New York|
|CAREMAX Surgical, P.C.|
|East Patchogue, New York, United States, 11772|
|St. Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10025|
|United States, Texas|
|Surgical Consultants of San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Edward Phillips, MD||Cedars Sinai|