Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) for Gastric Reduction
Condition: Obesity
Study type: Interventional

Summary: 
      Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty
      (EVG) using an endoluminal-suturing device.

      Briefly, 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 (ie, 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.

      Study duration and number of subjects A period of approximately 6 months is anticipated form
      the time the time the first patient is enrolled to the completion of the last patient.

      The participants will be followed as follow:

      Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects
      observed)

      1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical
      assessment 6 month: Final assessment (Endoscopically and Clinical) On Parallel a nutritional
      specialist will monitor the patient on quarterly basis (1,3,6,12).

      Study procedures The intervention will be performed under general anesthesia with tracheal
      intubation. Endomina will be introduced into the stomach over guide wires and then fixed to
      the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior
      sutures after argon plasma coagulation of the tissue opposition areas in order to ensure
      persistence of the pouch reduction. Patient will be kept overnight after the procedure.
    

Detailed description: 
      Surgery is 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 later 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.1
      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. 3 A transoral or endoluminal approach (ie, 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. 4

      Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot driven device that may
      be attached to an endoscope inside the body and allows remote manipulation of the arms of
      devices during a peroral intervention. It offers the possibilities of making transoral
      surgical full thickness sutures and may allow performing, via a transoral route.

      Study design Prospective, non-randomized, open-label, single-center safety and feasibility
      study

      Objectives:

      Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using
      an endoluminal-suturing device.
    

Intervention name(s): ENDOMINA
Intervention type(s): Device
Intervention description(s): Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment