Endorail in Long Lasting Colonoscopy
Condition: Colonoscopy; Incomplete Colonoscopy
Study type: Interventional

Summary: 
      Patients with long lasting colonoscopy are characterized by higher risk of incompletion.
      Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope
      in the large intestine. Endorail works as a magnetic anchor that is able to guide the
      colonoscope and to straighten colon curves and loops. The aim of this study is to test the
      safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting
      colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75
      years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time
      greater than 10 minutes will take part in the study. The primary efficacy endpoint is the
      percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety
      endpoints are the absence of device-related serious adverse events and the evaluation of the
      equality or reduction of the adverse events rates compared to diagnostic colonoscopies
      without Endorail.
    

Detailed description: 
      Patients with long lasting colonoscopy are characterized by higher risk of incompletion. A
      colonoscopy can be defined as incomplete when the endoscopist cannot reach the caecum. Caecal
      intubation is one of the main goals of colonoscopy and represents a diagnostic quality
      indicator. International guidelines recommend caecal intubation rates ≥90% for all
      colonoscopies in daily clinical practice. Reported incomplete colonoscopy rates range from 4%
      to 25%. Caecal intubation fails in 4-10% of cases in tertiary referred centres, instead in
      national surveys colonoscopies are incomplete in 10-25% of cases.

      Endorail is a medical device intended to facilitate the positioning of a standard
      colonoscope. Endorail is a colonoscopy add-on device that works as a magnetic anchor able to
      guide the colonoscope and to straighten colon curves and loops.

      Endorail is composed by the following two CE marked medical devices: Endorail Set and
      Endorail System. Endorail Set consists of the Endorail Balloon Guide, The Endorail Solution
      Syringe, The Endorail Powder and the Spike. Endorail System consists of the Endorail
      Handpiece and the Endorail Cart.

      The aim of this study is to test the safety and efficacy of the Endorail in ensuring that
      incompletion rate in long-lasting colonoscopies is lower than the 10% threshold.

      Outpatients of either sex aged between 22-75 years, undergoing elective colonoscopy for
      diagnostic or surveillance colonoscopy, who have signed a written informed consent and
      presenting caecal intubation time greater than 10 minutes, will take part in the study. The
      study plan will include a screening/baseline/treatment visit (Visit 1/Day 1), during which
      colonoscopy with the investigational medical device Endorail will be performed and a phone
      follow-up visit (Visit 2), scheduled at 7 (± 1) day after treatment with the investigational
      medical device Endorail.

      The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete
      long-lasting colonoscopies

      The primary safety endpoints are:

        -  The absence of device-related serious adverse events. AND

        -  The evaluation of the equality or reduction of the adverse events rates compared to
           diagnostic colonoscopies without Endorail.
    

Intervention name(s): ENDORAIL
Intervention type(s): Device
Intervention description(s): In case caecal intubation time is longer than 10 minutes, the balloon catheter is inserted in the tool channel, advanced beyond the colonoscope tip and filled with Ferromagnetic Fluid. By applying the Endorail Handpiece over the patient abdomen, the balloon can be magnetically anchored. The anchored balloon guide allows to straighten the scope and the colon itself. The colonoscope can thus be easily moved back and forward along the anchored guide to facilitate colonoscope positioning and colonoscopy completion. Afterward, Endorail is removed and the straightened colonoscope can be easily pushed forward to achieve colonoscopy completion according to standard endoscopic technique.
Other intervention name(s): Endorail Set - Endorail System
Intervention model: Single Group Assignment
Intervention model description: Multi Centre, Post Market, Single Arm, Open-Label, Interventional Study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Medical Device; Colonoscopy; Gastrointestinal endoscopy; Magnetic Balloon Technology; Looping; Safety; Effectiveness