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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Ethicon Endo-Surgery

Current Primary Outcome:

  • 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.


Original Primary Outcome:

  • *Effectiveness of the SAGB post-operatively (for the follow-up period)
  • *Rate of device-related adverse events and SAGB malfunctions in subjects implanted with the SAGB throughout the post-operative follow-up period.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • *Changes in excess body weight throughout post-operative follow-up period
  • *Change in body mass index (BMI) throughout the post-operative follow-up period
  • *Absolute weight loss and percent change in absolute weight throughout the post-operative follow-up period
  • *Change in Quality of Life measures throughout the post-operative follow-up period
  • *Changes in specific laboratory test values throughout the post-operative follow-up period
  • *Rate of all adverse events in subjects implanted with the SAGB throughout the post-operative follow-up period.


Information By: Ethicon Endo-Surgery

Dates:
Date Received: September 9, 2005
Date Started: June 2003
Date Completion:
Last Updated: August 3, 2015
Last Verified: August 2015