A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
1 other identifier
observational
231
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 22, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
February 7, 2014
CompletedFebruary 7, 2014
January 1, 2014
2.5 years
October 20, 2009
August 14, 2013
January 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Excess Weight Change From 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.
Baseline to 24 months
Secondary Outcomes (2)
% Excess Weight Change From Baseline to 12 Months
Baseline to 12 months
Change in Body Mass Index From Baseline to 24 Months
Baseline to 24 months
Eligibility Criteria
At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.
You may qualify if:
- Received an implant with the Realize Band-C according to the following indications for use:
- 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.
- Male and female adult patients (adult is defined as 18 years of age or older)
- Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.
- Able to comprehend, follow, and give signed informed consent.
You may not qualify if:
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
- Severe cardiopulmonary disease or other serious organic disease;
- Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
- Portal hypertension;
- Anomalies of the gastrointestinal tract such as atresia or stenosis;
- Cirrhosis of the liver;
- Chronic pancreatitis;
- Localized or systemic infection;
- On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;
- Unable or unwilling to comply with dietary restrictions required by this procedure;
- Known allergy to materials contained in the gastric band or its Injection Port;
- Women who are pregnant;
- Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Celebration, Florida, United States
Unknown Facility
Joliet, Illinois, United States
Unknown Facility
Holland, Michigan, United States
Unknown Facility
Patchogue, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Houston, Texas, United States
Related Publications (2)
Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Schwiers M, Gutierrez M. Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):885-93. doi: 10.1016/j.soard.2013.02.009. Epub 2013 Mar 14.
PMID: 23642493RESULTCunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Rodriguez CE, Gutierrez M. Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population. Surg Obes Relat Dis. 2012 May-Jun;8(3):288-95. doi: 10.1016/j.soard.2011.05.004. Epub 2011 May 20.
PMID: 21775219RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Schwiers, Principal Biostatistician
- Organization
- Ethicon Endo-Surgery, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 22, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
February 7, 2014
Results First Posted
February 7, 2014
Record last verified: 2014-01