Clinical trial NCT00999661: A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2009-10-22
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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.

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.


Eligibility 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.

Primary outcomes:
measure: Percent Excess Weight Change From Baseline to 24 Months
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: % Excess Weight Change From Baseline to 12 Months
timeFrame: Baseline to 12 months
measure: Change in Body Mass Index From Baseline to 24 Months
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Celebration
country: United States
state: Florida
city: Joliet
country: United States
state: Illinois
city: Holland
country: United States
state: Michigan
city: Patchogue
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
Study officials:
References:
citation: 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.
citation: Cunneen 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.