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NCT04820036 · ClinicalTrials.gov registry record · NA
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
A NA study of Obesity and Non-alcoholic Steatohepatitis (NASH), sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04820036 is a NA study of Obesity and Non-alcoholic Steatohepatitis (NASH) that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04820036, a NA study of Obesity and Non-alcoholic Steatohepatitis (NASH), is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Insulin Resistance
- BEHAVIORAL Quality of Life Assessment
- DIAGNOSTIC_TEST Liver Function Test
- DIAGNOSTIC_TEST Radiologic features of NASH
- DIAGNOSTIC_TEST Serologic features of NASH
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2027-12-24 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04820036
The ClinicalTrials.gov registry entry for NCT04820036 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Obesity appearing as the primary indexed condition, and to 5 interventions - of which Insulin Resistance is the first listed.
NCT04820036 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04820036 about?
NCT04820036 is a clinical study titled "A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)". Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-al...
What is the current status of trial NCT04820036?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2021-05-06. Estimated completion is 2027-12-24.
What conditions does trial NCT04820036 study?
This clinical trial studies the following conditions: Obesity, Non-alcoholic Steatohepatitis (NASH), Non-Alcoholic Fatty Liver Disease (NAFLD), Endoscopic Sleeve Gastroplasty, Liver Fibroses.
What interventions are being tested in trial NCT04820036?
The interventions under investigation include: Insulin Resistance (DIAGNOSTIC_TEST), Quality of Life Assessment (BEHAVIORAL), Liver Function Test (DIAGNOSTIC_TEST), Radiologic features of NASH (DIAGNOSTIC_TEST), Serologic features of NASH (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04820036?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04820036 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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