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Evaluation of an Endoscopic Sutured Gastroplasty in Patients With NonAlcoholic Steatohepatitis (NASH) and Fibrosis.

NCT04653311 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-02

No results posted yet for this study

Summary

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately hepatocellular carcinoma and liver failure. NASH is also recognized as an independent cardiovascular risk factor. Currently, weight loss is the only validated treatment for NASH and also positively affect all the features of metabolic syndrome. Considering the known positive metabolic effects of bariatric surgery, efforts have been exerted to develop minimally endoscopic procedures aiming to induce weight loss. Therefore, we would like to evaluate in patients with NASH disease and fibrosis, the impact of an endoscopic sutured gastroplasty (with Endomina® device) on:

* Mainly liver histological endpoints but also,
* Surrogate markers of hepatic inflammation and fibrosis and
* Surrogate markers of insulin resistance as well as fasting lipid and glycemic profiles.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DEVICE

Endomina®

Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year

Sponsors & Collaborators

  • Epidemiological and Clinical Research Information Network

    collaborator OTHER

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Jacques Deviere, MD, phD · CUB Hôpital Erasme, Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2023-06-23
Completion
2023-12-23

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653311 on ClinicalTrials.gov