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

NCT ID: NCT00543140

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2015-01-31

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REALIZE™ Swedish Adjustable Gastric Band

All subjects have the REALIZE™ Swedish Adjustable Gastric Band. Single arm - no comparator.

Group Type: OTHER

REALIZE™ Swedish Adjustable Gastric Band

Intervention Type: DEVICE

Laparoscopic placement of the Swedish Adjustable Gastric Band

Interventions

REALIZE™ Swedish Adjustable Gastric Band

Laparoscopic placement of the Swedish Adjustable Gastric Band

Intervention Type: DEVICE

Other Intervention Names

REALIZE Band

Eligibility Criteria

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.

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).

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Sinai

Locations

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

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

Countries

United States

Other Identifiers

CI-06-0001/CI-07-0006

Identifier Type: -

Identifier Source: org_study_id

NCT00813462

Identifier Type: -

Identifier Source: nct_alias