Clinical trial NCT00543140: Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
Keywords: Obesity
Morbid Obesity
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.
timeFrame: 5 years
measure: Percent Change in Excess Body Weight at 5 Years Post-implant
timeFrame: 5 years
measure: Change in SF-36 Health Survey Physical Component at 5 Years Post Implant
timeFrame: 5 years
measure: Change in SF-36 Health Survey Mental Component at 5 Years Post Implant
timeFrame: 5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Surgical Associates of La Jolla Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Miami
country: United States
facility: Advanced Surgical Institute at Mercy Hospital
state: Florida
city: St. Augustine
country: United States
facility: Robert T. Marema, MD
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Dalton
country: United States
facility: Hamilton Medical Center - Weight Management
state: Georgia
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: San Antonio
country: United States
facility: dgd Research, Inc.
state: Texas
Study officials:
affiliation: Cedars Sinai
name: Edward Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: