Apollo Endosurgery has enrolled its final patient in the Multi-Center ESG Randomized Interventional Trial (Merit ), which is evaluating the effectiveness of the endoscopic sleeve gastroplasty (ESG) procedure.
The multi-centre-controlled trial of ESG is being conducted at nine sites in the US.
The minimally invasive weight loss procedure is based on full-thickness endoscopic suturing using Apollo’s OverStitch system. This system enables advanced surgery by allowing physicians to place full-thickness sutures from a flexible endoscope.
The technology also enables a secure approximation of tissue endoscopically and a range of less invasive solutions for physicians who treat upper as well as lower GI tract defects of their patients.
In this process, a series of sutures are placed through the gastric wall, reducing the stomach volume by up to 80% and creating a restrictive endoscopic sleeve.
The trial is aimed at demonstrating weight loss and quality of life at 12 months following the ESG procedure. It will also measure improvement in hypertension and type 2 diabetes at 24 months versus control.
Safety and effectiveness of the MERIT trial are based on endpoint outlines in a consensus statement of the American Society of Gastrointestinal Endoscopy (ASGE) and the American Society of Metabolic Bariatric Surgery (ASMBS).
A total of 200 patients were enrolled in the trial. ESG participants who fail to meet the endpoints will receive a repeat upper endoscopy at 52 weeks +/- four weeks to evaluate stitch placement and will be thereafter followed up at 12 months.
Control participants will follow a low-calorie, healthy lifestyle intervention for a year and may later be eligible for crossover to receive the ESG procedure.
On 13 June, Apollo Endosurgery said the company received FDA approval for its proposed labelling updates for the ORBERA Intragastric Balloon System.