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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: REALIZE™ Swedish Adjustable Gastric Band


Participation Criteria
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Eligibility Criteria
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CI-06-0001 Inclusion Criteria: Subjects eligible to participate in this study must fulfill all of the following 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; and Living within the contiguous U.S. CI-07-0006 Inclusion Criteria: Subjects eligible to participate in this study must fulfill all of the following criteria: Able to comprehend, follow and give informed consent; 18 to 60 years of age (inclusive); Body Mass Index (BMI) of > 40 kg/m2 and £ 55 kg/m2, or BMI ³ 35 kg/m2 and < 40 kg/m2 with one or more co-morbid conditions. Candidate for surgical weight loss intervention in accordance with the Instructions For Use (i.e., meets acceptable health criteria for major surgery). CI-06-0001 Exclusion Criteria: Subjects with the following are not eligible to participate in this clinical trial and must not be enrolled in this study: a. Consented to, and participated in EES Protocol CI-02-0006 titled A aSingle-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. CI-07-0006 Exclusion Criteria: Women who are currently pregnant. Previous malabsorptive or restrictive procedures performed for the treatment of morbid obesity. Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit (1a). Presence of any of the following medical conditions; Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease; Severe cardiopulmonary disease or other serious organic disease; Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases; Portal hypertension; Anomalies of the gastrointestinal tract such as atresia or stenosis; Cirrhosis of the liver; Chronic pancreatitis; Patients on chronic, long-term steroid treatment or steroids within 15 days of surgery; Unable or unwilling to comply with dietary restrictions required by this procedure; Known allergy to materials contained within the band or its injection port (silicone elastomer containing 10% BaSO4, polyetheretherketone (PEEK), and cobalt chromium) Presence of terminal illness with life expectancy of £ 5 years. Inability to refrain from use of anticoagulants or aspirin within 15 days prior to surgery. Acute or chronic infection (localized or systemic). Participation in another clinical trial within 8 weeks of the Screening Visit (1a) and for the duration of this trial. Any medical condition or finding for which the Investigator utilizes their medical discretion to determine the subject should be excluded due to inability to understand or follow study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: REALIZE™ Swedish Adjustable Gastric Band<br>All subjects have the REALIZE™ Swedish Adjustable Gastric Band. Single arm - no comparator. | Device: REALIZE™ Swedish Adjustable Gastric Band<br>* Laparoscopic placement of the Swedish Adjustable Gastric Band<br>* Other names: REALIZE Band;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 
| Percent Change in Excess Body Weight at 5 Years Post-implant |  | 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. | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Morbid Obesity