Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00580502
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00580502
Study Brief:
Protocol Section:
NCT00580502