A Study to Evaluate the Combining of Endoscopic Ultrasound Guided Liver Biopsy and Stomach Balloon Placement for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease and Obesity
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-009262
NCT ID: NCT02880189
Sponsor Protocol Number: 15-009262
About this study
The purpose of this study is to evaluate the usefulness of combining a core liver biopsy guided by endoscopic ultrasound and stomach balloon placement by endoscope for the diagnosis and treatment of fatty liver disease and obesity.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Nonalcoholic steatohepatitis patients with evidence of early fibrosis on MRE-Hepatogram
- Referred for an intragastric balloon placement for weight loss
Exclusion Criteria
- Age ≤ 21 or ≥ 70 years
- Pregnancy, plan for pregnancy or lactating
- Previous history of gastric surgery
- Current or recent (within 6 months) gastric or duodenal ulcers
- Gastroparesis
- Liver cirrhosis
- Coagulopathy or active use of anticoagulation
- Inability to provide a written informed consent
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Barham Abu Dayyeh, M.D., M.P.H. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available