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 @ 3:05 AM
Ignite Modification Date:
2025-12-25 @ 3:05 AM
NCT ID:
NCT01399333
Eligibility Criteria:
Inclusion Criteria:
* Persons that are scheduled to undergo the adjustable gastric banding (AGB) surgery utilizing the AP Lap-Band System.
* Not having any medical confounding factors as described in exclusion criteria.
* Willing to comply with food and exercise logs and comply with the full-liquid diet, both pre-and-post-operatively.
Exclusion Criteria:
* Persons who are not undergoing AGB surgery or are unwilling to comply with study methods or are medically not eligible.
* Taking diuretics
* Have been diagnosed with unstable diabetes, unstable neurologic conditions, unstable cardiac conditions or gastro-intestinal disorders, renal dysfunction, wounds, and autoimmune disorders that may increase protein needs.
* Uncontrolled gastrointestinal disease, such as Crohn's disease, diverticulitis, Celiac disease, or ulcerative colitis.
* Active malignancy
* Patients will also be excluded if pre-operative vitamin deficiencies are not corrected by surgery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01399333
Study Brief:
Protocol Section:
NCT01399333