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:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT03186859
Eligibility Criteria:
Inclusion Criteria:
* Bariatric surgery is already planned for the participant
* Participant is willing and able to give informed consent for participation in the study.
* Aged ≥18 or ≤75 years.
* Body Mass Index ≥35 ≤55 kg/m2
Exclusion Criteria:
* Contraindication to MRI
* Prior or current participation in a CTIMP that could affect study results
* History of alcoholism or a greater than recommended weekly alcohol intake (14 units per week)
* History of albumin allergy
* Anticoagulant treatment
* Pregnant or nursing mothers
* Type 2 Diabetes
* A liver disease other than NAFLD
* Histological confirmation of lack of NAFLD on liver biopsy
* Large hiatus hernia (that would prohibit Sleeve Gastrectomy)
* Active gastrooesophageal reflux disease (that would prohibit Sleeve Gastrectomy)
* Active malabsorptive intestinal disease (that would prohibit Roux-en-Y Gastric Bypass surgery)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03186859
Study Brief:
Protocol Section:
NCT03186859