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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00999661
First received: October 20, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Percent Excess Weight Change From Baseline to 24 Months [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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:
  • % Excess Weight Change From Baseline to 12 Months [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 231
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999661

Locations
United States, California
Los Angeles, California, United States
United States, Florida
Celebration, Florida, United States
United States, Illinois
Joliet, Illinois, United States
United States, Michigan
Holland, Michigan, United States
United States, New York
Patchogue, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Ethicon Endo-Surgery
  More Information

Publications:
Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00999661     History of Changes
Other Study ID Numbers: CI-09-0007
Study First Received: October 20, 2009
Results First Received: August 14, 2013
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014