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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT01682733
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 30 and 40
* Age \>18 and ≤50
* Stable weight for 3 months (within 5% of BMI)
* Normal basic labs (CBC, chemistry profile, creatinine)
* Negative pregnancy test for females \>18 or ≤ 50
Exclusion Criteria:
* Diabetes
* Unstable coronary artery disease
* Heart failure
* Cardiac arrhythmia
* Cardiac valvular disease
* Obstructive of interstitial lung disease
* Females of child-bearing age \>18 or ≤ 50 who are pregnant or lactating
* Mallampati score of 4
* ASA 3 or above
* Previous gastric surgery
* Ulcer disease
* Gastroparesis,
* \> 5 cm Hiatal hernia
* Congenital anomalies of the GI tract
* Currently on or prescribed a medication known to affect weight within 3 months of study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01682733
Study Brief:
Protocol Section:
NCT01682733