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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01754194
Eligibility Criteria:
Inclusion Criteria:
* All patients aged from 18 to 65 years of age, inclusive
* BMI \> 40 or BMI \> 35 with co-morbidities
* Eligible for weight-loss surgery
* Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
* Insurance approval status: approved
* Written informed consent
Exclusion Criteria:
* BMI \> 55
* Planned two-stage procedures
* Prior bariatric procedures (including gastric banding)
* Serious mental or physical co-morbidities at the discretion of the Investigator
* Insurance approval status: rejected
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01754194
Study Brief:
Protocol Section:
NCT01754194