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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00543140
First received: August 28, 2007
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Morbid Obesity
Device: REALIZE™ Swedish Adjustable Gastric Band
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.

  • Percent Change in Excess Body Weight at 5 Years Post-implant [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in SF-36 Health Survey Physical Component at 5 Years Post Implant [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Change in SF-36 Health Survey Mental Component at 5 Years Post Implant [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 303
Study Start Date: August 2006
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
REALIZE™ Swedish Adjustable Gastric Band
All subjects have the REALIZE™ Swedish Adjustable Gastric Band. Single arm - no comparator.
Device: REALIZE™ Swedish Adjustable Gastric Band
Laparoscopic placement of the Swedish Adjustable Gastric Band
Other Name: REALIZE Band

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543140

Locations
United States, California
Surgical Associates of La Jolla Medical Group, Inc.
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Advanced Surgical Institute at Mercy Hospital
Miami, Florida, United States, 33133
Robert T. Marema, MD
St. Augustine, Florida, United States, 32086
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Hamilton Medical Center - Weight Management
Dalton, Georgia, United States, 30722
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
United States, Texas
dgd Research, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Edward Phillips, MD Cedars Sinai
  More Information

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00543140     History of Changes
Obsolete Identifiers: NCT00813462
Other Study ID Numbers: CI-06-0001/CI-07-0006 
Study First Received: August 28, 2007
Results First Received: January 11, 2016
Last Updated: February 9, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:
Obesity
Morbid Obesity

Additional relevant MeSH terms:
Obesity, Morbid
Body Weight
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016