Loading clinical trials...

A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C | Clinical Trials | Clareo Health

COMPLETED

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

A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients

NCT00999661•Ethicon Endo-Surgery

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria

Locations (7)

Los Angeles, California, United States

Celebration, Florida, United States

Joliet, Illinois, United States

Holland, Michigan, United States

Patchogue, New York, United States

Charlotte, North Carolina, United States

Houston, Texas, United States

Key Dates

Start Date

November 1, 2009

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

February 7, 2014

Enrollment

231

ACTUAL participants

Conditions

Morbid Obesity

Dairy Lipids and Cardiometabolic Risk

NCT05783466

Morbid Obesity

View study

RECRUITINGNA

Bougie Sleeve Trial

NCT02937649

Morbid Obesity

View study

RECRUITINGNA

FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

NCT06268990

Morbid Obesity

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Dairy Lipids and Cardiometabolic Risk

Bougie Sleeve Trial

FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

Stool Analysis After Sleeve Gastrectomy vs Gastric Bypass

Sleeve Gastrectomy Outcomes With Different Stapling Devices

Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery