Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band (SAGB-PM)

Ethicon

Status and phase

Completed

Phase 4

Conditions

Morbid Obesity

Treatments

Device: REALIZE™ Swedish Adjustable Gastric Band

Study type

Interventional

Funder types

Industry

Identifiers

NCT00543140

CI-06-0001/CI-07-0006

Details and patient eligibility

About

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.

Full description

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.

Enrollment

303 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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;
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)
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.