The MERIT study is a multi-centre, prospective randomised clinical trial evaluating the safety and effectiveness of the Endoscopic Sleeve Gastroplasty (ESG) procedure
Medical technology company Apollo Endosurgery has published the results of its Multi-centre ESG Randomised Interventional Trial (MERIT) Study in The Lancet.
The MERIT study is a prospective clinical trial evaluating the safety and effectiveness of the Endoscopic Sleeve Gastroplasty (ESG) procedure.
The procedure, a minimally invasive endoscopic weight loss procedure, was performed with Apollo’s Endosurgery’s OverStitch Endoscopic Suturing System.
In the study, patients with Body Mass Index (BMI) ≥30 and ≤40 kg/m² were randomised to treatment with ESG and lifestyle modification or to a control group which involved lifestyle modification alone.
Qualifying patients in the control group were given the opportunity to switch to the ESG after the primary endpoint (52 weeks) if they complied with specific requirements.
It was conducted across nine US centres representing both gastroenterology and bariatric surgery practices from academic and community settings.
The study was completed by 137 participants after a 52-week follow-up period (68 treatment and 89 control subjects).
At 52 weeks, 72 control patients switched to receiving therapy, and both groups continued to be monitored for an additional 52 weeks.
For the patients undergoing ESG, 49.2% excess body weight loss at 12 months in the treatment group was noted.
In the responder group, 16.3% average total body weight loss was reported and 68.3% of responders maintained at least 25% EWL at 104 weeks.
The results also had the pattern of improvements in quality of life, eating behaviours, and depression, said the company.
According to the publication, 3 ESG patients (2.0%) experienced a device or procedure-related serious adverse event, all of which resolved and did not require intensive care or surgical intervention.
Apollo Endosurgery president and CEO Chas McKhann said: “The publication of this randomized trial in such a high impact and influential journal as The Lancet speaks to the significance of its findings and implications for patients who suffer from obesity.
“The results of the study are a strong testament to the opportunity that we have at Apollo to expand the therapeutic spectrum of obesity and metabolic care to affect real change in the obesity epidemic.”