Trials / Completed
CompletedNCT02880189
EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 22 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on magnetic resonance elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Orbera Intragastric Balloon | The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically. |
| PROCEDURE | Endoscopic Ultrasound Guided Core Liver Biopsy |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-03-13
- Completion
- 2018-03-13
- First posted
- 2016-08-26
- Last updated
- 2022-06-15
- Results posted
- 2019-04-18
Source: ClinicalTrials.gov record NCT02880189. Inclusion in this directory is not an endorsement.