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.
NCT00543140 (CI-06-0001) is the 2 year Safety and QOL subject follow-up study to NCT00166205 (CI-02-0006), completed on November 10, 2008. As a condition of approval, the FDA required additional subjects with long-term safety data. These subjects enrolled under protocol CI-07-0006 (NCT00813462)-5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric Band. Protocol CI-06-0001 was amended to combine these study subjects with study subjects from CI-07-0006. NCT00543140 (CI-06-0001) will not be completed (analysis of results) until the additional subjects in NCT00813462 (CI-07-0006) complete this study since the original intent was to pool the data together from the above two studies to obtain the appropriate sample size for estimation of the re-operation rate at 4 and 5 years post implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
303
Laparoscopic placement of the Swedish Adjustable Gastric Band
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
Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.
A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and * Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device.
Time frame: 5 years
Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.
The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.
Time frame: 5 years
Percent Change in Excess Body Weight at 5 Years Post-implant
Time frame: 5 years
Change in SF-36 Health Survey Physical Component at 5 Years Post Implant
Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.
Time frame: 5 years
Change in SF-36 Health Survey Mental Component at 5 Years Post Implant
Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.
Time frame: 5 years
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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