Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI)… (NCT00580502) | Clinical Trial Compass
CompletedPhase 2/3
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
50 participantsStarted 2004-03
Plain-language summary
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be at least 18 and equal to or less than 60 years of age.
* BMI of at least 30 and maximum BMI of 40 with co-morbidities
* Willingness to comply with dietary restrictions required by the protocol
* History of obesity for at least 5 years
* History of at least 6 months of documented failures with traditional non-surgical weight loss methods
* Willingness to follow protocol requirements
* If female with childbearing potential, using an appropriate form of contraception
Exclusion Criteria:
* Age less than 18, age greater than 60
* Pregnancy
* History of major depressive disorder or psychosis
* Previous bariatric surgery or previous gastric surgery
* Presence of achalasia
* Presence of portal hypertension, cirrhosis, and/or varices
* Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
* Patients with autoimmune connective tissue disorders
* Patients with acute abdominal infections
* Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study
What they're measuring
1
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery