A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT00999661
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-22
• Study Start: 2009-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-08-14
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Results First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

1. Received an implant with the Realize Band-C according to the following indications for use:

   1. Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions.
   2. Male and female adult patients (adult is defined as 18 years of age or older)
   3. Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.

2. Able to comprehend, follow, and give signed informed consent.

Exclusion Criteria

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. Localized or systemic infection;
9. On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;
10. Unable or unwilling to comply with dietary restrictions required by this procedure;
11. Known allergy to materials contained in the gastric band or its Injection Port;
12. Women who are pregnant;
13. Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Excess Weight Change From Baseline to 24 Months	Baseline to 24 months	Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.

Secondary Outcome Measures

Name	Time	Method
% Excess Weight Change From Baseline to 12 Months	Baseline to 12 months	Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
Change in Body Mass Index From Baseline to 24 Months	Baseline to 24 months	Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.