A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction.
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      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 (1,2).

      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 (3,4).

      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 (5).
    

Detailed description: 
      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.

      After a first trial on pigs (safety) we did a second trial on human. This trial included 11
      patients treated with the same technique. There were no complications and the short term
      results were encouraging.

      Study design:

      Prospective, non-randomized, interventional, open-label, multi-center efficacy study.

      Objectives:

      Study to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an
      endoluminal-suturing device. In the literature the efficacy of an endoluminal technique is
      defined as a loss of weight of 25% excess weight loss (EWL) sustained at 1 year (6).

      Endpoints Secondary endpoint: Efficacy Information on efficacy will be obtained by
      measurements of total weight loss and excess weight loss during 12 months Secondary endpoint:
      Safety Safety will be characterized by the incidence of all Adverse Device Effects (ADEs),
      non-serious and serious, possibly related to or related to the procedure and/or device that
      are experienced by study participants.

      In addition, safety assessments will be determined based on physical examination (vital
      signs) and laboratory tests during scheduled visits. Safety evaluations will also be
      performed to ensure no subsequent adverse events have occurred and to ensure any adverse
      events during the trial that are considered on-going are stable or have resolved. Safety will
      be assessed at 1, 3, 6 and 12 months following the intervention.

      Sample size •40 patients will be enrolled Based on the result of our previous study, with a
      beta power of 80% and an alpha error of 5%, the number of patient needed to detect a 25% EWL
      reduction at one year is 34. Considering a lost to follow-up of 10%, 40 patients is required.

      Study duration:

      •6 months of enrolment and 12 months of follow up Overall design This will be a prospective,
      non-randomized, open-label, multi-center, interventional, efficacy study.

      A period of approximately 6 months is anticipated form the time the first patient is enrolled
      to the completion of the last patient. There will be no randomization in this study.

      Once baseline eligibility criteria have been met all patients will undergo the same treatment
      protocol. A subject will be considered "enrolled" if he/she has signed the informed consent,
      passed all screening criteria and has undergone a procedure.

      Criteria for discontinuation If a subject discontinues participation in the study, he or she
      will be contacted in order to obtain information about the reason(s) for discontinuation and
      collection of any potential AEs. The Investigator will document the reason for Subject
      Withdrawal on the Patient Case Report Form (CRF). Discontinued patients will be followed
      until all AEs resolve or until the Investigator decides that follow-up are no longer
      necessary.

      Study Design:

      Devices used during the protocol In addition to Endomina device (provided as companionate by
      Endotools Options) any other required endoscopic accessories can be used during the
      procedure.

      Point of enrollment A subject will be considered "enrolled" if he/she has signed the informed
      consent, passed all screening criteria and has agreed to the procedure.

      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.

      Lab tests and other screening procedures can occur as early as 30 days prior to scheduled
      procedure.

      The participants will be followed as follow:

        -  Day (-1): Admission

        -  Day (0): Procedure

        -  Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed)

        -  1 month: Clinical assessment

        -  3 month: Follow up endoscopy, Clinical assessment

        -  6 month: Clinical assessment

        -  12 month: Clinical and endoscopic assessment 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.
    

Intervention name(s): Endomina
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment