A Study of Clinical Outcomes of the REA… | Clinical Trial

Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Percent Excess Weight Change From Baseline to 24 Months

Time frame: 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 outcomes

% Excess Weight Change From Baseline to 12 Months

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Oct 22, 2009
Registry last updated: Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed