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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery