Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Intervention: REALIZE™ Swedish Adjustable Gastric Band
Intervention description: Laparoscopic placement of the Swedish Adjustable Gastric Band
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Obesity; Morbid Obesity

Summary:

      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.
    

Eligibility criteria:

        CI-06-0001 Inclusion Criteria:

        Subjects eligible to participate in this study must fulfill all of the following criteria:

          1. Able to comprehend, follow and give signed informed consent;

          2. 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";

          3. Currently have an SAGB implant in place;

          4. Able to commit to long-term follow-up; up to 5 years after SAGB implantation,
             including band adjustment visits; and

          5. 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:

          1. Able to comprehend, follow and give informed consent;

          2. 18 to 60 years of age (inclusive);

          3. 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.

          4. 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:

          1. Women who are currently pregnant.

          2. Previous malabsorptive or restrictive procedures performed for the treatment of morbid
             obesity.

          3. Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit
             (1a).

          4. Presence of any of the following medical conditions;

               1. Inflammatory diseases of the gastrointestinal tract, including severe intractable
                  esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation
                  such as Crohn's disease;

               2. Severe cardiopulmonary disease or other serious organic disease;

               3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices
                  or intestinal telangiectases;

               4. Portal hypertension;

               5. Anomalies of the gastrointestinal tract such as atresia or stenosis;

               6. Cirrhosis of the liver;

               7. Chronic pancreatitis;

               8. Patients on chronic, long-term steroid treatment or steroids within 15 days of
                  surgery;

               9. Unable or unwilling to comply with dietary restrictions required by this
                  procedure;

              10. Known allergy to materials contained within the band or its injection port
                  (silicone elastomer containing 10% BaSO4, polyetheretherketone (PEEK), and cobalt
                  chromium)

          5. Presence of terminal illness with life expectancy of £ 5 years.

          6. Inability to refrain from use of anticoagulants or aspirin within 15 days prior to
             surgery.

          7. Acute or chronic infection (localized or systemic).

          8. Participation in another clinical trial within 8 weeks of the Screening Visit (1a) and
             for the duration of this trial.

          9. 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.