ENDONASH
Research type
Research Study
Full title
A multi-centre, controlled study to evaluate the efficacy and safety of an Endoscopic Sutured Gastroplasty (with Endonima device) in patients with non-alcoholic steatohepatitis (NASH) and fibrosis
IRAS ID
289862
Contact name
Ashley Barnabus
Contact email
Sponsor organisation
Erasme University Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) is the most common type of chronic liver disease worldwide, whereby it affects 25% of the population. It is considered an increasing public health issue due to its close association with the epidemic of obesity and type 2 diabetes.
Beyond lifestyle modifications, bariatric surgery has shown powerful corrective effects. However, bariatric surgery remains an invasive approach with a risk of significant complications and is still considered only for morbidly obese patients. Furthermore, invasive bariatric surgery might even be contraindicated in patients with advanced liver disease because of elevated operative risk.
This study will be using Endomina, a CE marked device. It is a suturing device that will be attached to an endoscope inside the body which allows remote use of the device. During the procedure (endoscopic sleeve gastroplasty) the gastric wall tissue is folded several times and sutured to create a sleeve; which reduces the size of the stomach. Sutures used during this procedure are equivalent to those used for other surgical techniques.
The aim of this trial is to evaluate the effect of an endoscopic sutured gastroplasty (with use of the Endomina device) on liver histology (as measured by resolution of NASH without worsening fibrosis). This will be in comparison to a control group who will be undertaking lifestyle interventional treatment.
This study aims to recruit 5-10 patients in the UK.
Exploratory substudies might be performed during the study in sites that have the corresponding capability. Each substudy is to be approved by the sponsor-institution prior to finalising the sub-study protocol. Specific study documents will be prepared and Independent Ethics Committee (IEC) and authority approvals shall be obtained when applicable.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0260
Date of REC Opinion
26 Jan 2022
REC opinion
Further Information Favourable Opinion