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

Morbid Obesity Clinical Trial

— SAGB-PM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543140
• Other study ID #: CI-06-0001/CI-07-0006
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2007
• Last updated: February 9, 2016
• Start date: August 2006
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00813462

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• REALIZE™ Swedish Adjustable Gastric Band
Laparoscopic placement of the Swedish Adjustable Gastric Band

Locations

Country	Name	City	State
United States	Hamilton Medical Center - Weight Management	Dalton	Georgia
United States	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	St. Luke's Roosevelt Hospital Center	New York	New York
United States	dgd Research, Inc.	San Antonio	Texas
United States	Robert T. Marema, MD	St. Augustine	Florida
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	5 years	Yes
Secondary	Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.	The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.	5 years	No
Secondary	Percent Change in Excess Body Weight at 5 Years Post-implant		5 years	No
Secondary	Change in SF-36 Health Survey Physical Component at 5 Years Post Implant	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.	5 years	No
Secondary	Change in SF-36 Health Survey Mental Component at 5 Years Post Implant	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.	5 years	No