A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
Condition: Screening Colonoscopy; Surveillance Colonoscopy
Study type: Interventional

Summary: 
      ME-APDS is a device (software-based with hardware) developed by Magentiq Eye LTD and intended
      to support the decision of the endoscopist on polyps which appear in the colonoscopy video
      during the colonoscopy procedure.

      This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq
      Eye Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC) in patients referred for
      either screening or surveillance colonoscopies.
    

Detailed description: 
      The primary objective of the present study is to compare the number of Adenomas Per
      Colonoscopy (APC) and the Adenomas Per Extraction (APE) between the Magentiq Eye-Assisted
      Colonoscopy (MEAC) and Conventional Colonoscopy (CC). These are also the co-primary
      endpoints.

      The secondary endpoints are Adenoma Miss Rate (AMR, tested on part of the total study
      population) and Adenoma Detection Rate (ADR).

      This study mainly hypothesizes that more adenomas will be detected in MEAC compared to CC
      (higher APC in MEAC compared to CC), and that the reduction of APE in MEAC compared to CC (if
      there will be a reduction) will be limited.

      The study also assumes that AMR will be reduced in MEAC compared to CC and that ADR will
      increase to some level in MEAC compared to CC.

      The study will include 952 subjects . Eligible patients will be randomized in a 1:1 ratio
      into two groups, group A and B. In group A, patients will be examined with CC. Patients in
      group B will be examined using MEAC. Immediately after the randomization, a sub-randomization
      will be performed on whether an immediate second examination (for AMR calculation) will be
      conducted or not (136 patients will undergo second examination).

      The colonoscopy will be performed in accordance with the standard of care of each medical
      center in either MEAC or CC.

      After the colonoscopy procedure patients will be observed at the endoscopy unit until the
      discharge criteria are met as per the standard clinical protocol of the medical center. After
      here, they will be discharged by the treating physician.

      Study follow-up period will be up to 30-days post-colonoscopy to register (serious) adverse
      events and it will be in accordance with the standard of care of medical center.
    

Intervention name(s): Screening or Surveillance Conventionall colonoscopy
Intervention type(s): Procedure
Intervention description(s): Patients in Group A (CC) will undergo Screening or Surveillance Conventual Colonoscopy, Patients in Group B (MEAC) will undergo Screening or Surveillance Colonoscopy with ME-ADPS Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Screening Colonoscopy; Surveillance Colonoscopy; Automatic Polyp Detection; Adenoma Per Colonoscopy; Adenoma Per Extraction; Adenoma Miss Rate; Adenoma Detection Rate