Endomina Controlled Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty
      (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular
      by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a
      delayed treatment control group (diet alone; crossover at 6 months) with a treatment group
      (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.
    

Detailed description: 
      Surgery is currently the only effective treatment for morbid obesity and can be divided into
      restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary
      pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

      This latter technique is the most common and most effective surgical procedure performed
      worldwide and has been processed to be an effective treatment of morbid obesity and its
      complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery.

      Vertical gastric plication is a novel surgical approach for reducing the stomach capacity.
      Anterior surface plication and greater curvature plication are variations of vertical gastric
      plication that reduce the gastric capacity through infolding of the anterior surface or
      greater curvature of the stomach, respectively. These approaches have been tested, with
      positive results.

      A transoral or endoluminal approach (i.e. a procedure that requires no incision, because
      access is granted through the mouth) offers the potential for additional benefit to the
      patient, because the procedures continue to become more and more minimally invasive.

      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring
      bariatric procedures performed via flexible endoscopy. Although these procedures may not be
      as effective as their surgical counterparts, these less-invasive options may relieve patients
      of the significant risks associated with surgery and might become part of the armamentarium
      of obesity management.

      Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be
      attached to an endoscope inside the body and allows remote actuation of the device during a
      peroral intervention. It offers the possibilities of making transoral full thickness tissue
      apposition and may allow performing, via a transoral route, large plications with tight
      serosa to serosa apposition.

      After a first trial on pigs (safety), a second trial on human patients was performed. This
      trial included 11 patients treated with the same technique. There were no complications and
      the short term results were encouraging with 41% EWL at 6 month.

      A multicentric trial NCT02582229 entitled: " A Prospective Study to Evaluate the Efficacy of
      an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. " is
      ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included
      in 3 European centers. Early results of the trial had showed that dietician follow-up is an
      important part of the success. During that time implementation of the procedure had been
      done.

      The aim of this trial is to compare a control group (diet alone) with a treatment group
      (Endomina procedure plus diet).
    

Intervention name(s): Endomina; Diet
Intervention type(s): Device; Behavioral
Intervention description(s): Endoscopic sleeve reduction; Multidisciplinary follow-up
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; endoscopy; endoscopic sleeve gastroplasty