N/A
Completed N=231
A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
Source: ClinicalTrials.gov NCT00999661 ↗Enrolled (actual)
231
Serious AEs
3.9%
Results posted
Feb 2014
Primary outcomePrimary: Percent Excess Weight Change From Baseline to 24 Months — 39.8 percent of excess weight at baseline — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Excess Weight Change From Baseline to 24 Months |
39.8 | <0.0001 sig |
| SECONDARY % Excess Weight Change From Baseline to 12 Months |
36.6 | <0.0001 sig |
| SECONDARY Change in Body Mass Index From Baseline to 24 Months |
-7.97 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00999661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.