Apollo Endosurgery Announces Publication in the Lancet of Landmark Study for the Endoscopic Sleeve Gastroplasty Procedure

 

The MERIT study is a multi-centre, prospective randomized clinical trial evaluating the safety and effectiveness of the Endoscopic Sleeve Gastroplasty (ESG) procedure, a minimally invasive, endoscopic weight loss procedure 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 randomized to treatment with ESG and lifestyle modification or to a control group which involved lifestyle modification alone. At the conclusion of the primary end point (52 weeks), qualifying patients in the control group were allowed to cross-over to ESG if they met certain conditions.

Nine US centers participated in the study, representing both gastroenterology and bariatric surgery practices from academic and community settings. One hundred and fifty-seven subjects completed the study through 52 weeks of follow-up (68 treatment and 89 control subjects). Seventy-two control patients crossed over to treatment at 52 weeks, and both groups were followed an additional 52 weeks.

 

Key results for patients undergoing ESG include:

  • 49.2% excess body weight loss at 12 months in the treatment group (vs 3.2% EWL in control)
  • 16.3% average total body weight loss in the responder group
  • 68.3% of responders maintained at least 25% EWL at 104 weeks
  • Improvements in quality of life, eating behaviours, and depression
  • Three 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.(2)

 

To read the full publication, visit
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01280-6/fulltext.
More information on the MERIT study can be found at clinicaltrials.gov (NCT03406975).

Author avatar
info@socreative.ie
http://icpobesity.org
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