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

Phase 4

Completed

• Conditions: Morbid Obesity
• Interventions: Device: REALIZE™ Swedish Adjustable Gastric Band

• Registration Number: NCT00543140
• Lead Sponsor: Ethicon Endo-Surgery

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-01-11
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-09
• Last Update Submitted: 2016-02-09
• Results First Posted: 2016-03-09
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	5 years	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

Name	Time	Method
Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.	5 years	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	5 years
Change in SF-36 Health Survey Mental Component at 5 Years Post Implant	5 years	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 Physical Component at 5 Years Post Implant	5 years	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.

Trial Locations

Locations (8)

Surgical Associates of La Jolla Medical Group, Inc.; 🇺🇸 La Jolla, California, United States

Hamilton Medical Center - Weight Management; 🇺🇸 Dalton, Georgia, United States

dgd Research, Inc.; 🇺🇸 San Antonio, Texas, United States

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States

Robert T. Marema, MD; 🇺🇸 St. Augustine, Florida, United States

Advanced Surgical Institute at Mercy Hospital; 🇺🇸 Miami, Florida, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States