A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy

A Randomized Two Arm Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Magentiq Eye's Automatic Polyp Detection System (ME-APDS) During Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Screening Colonoscopy; Surveillance Colonoscopy
• Intervention / Treatment: Procedure: Screening or Surveillance Conventionall colonoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 952
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Salzuflen, Germany, 32105
    • GastroZentrum Lippe
  • Mainz, Germany
    • Mainz University Medical Center
• Israel
  • Be'er Ya'aqov, Israel
    • Shamir Medical Center
  • Be'er Ya'aqov, Israel
    • Department of Gastroenterology, Shamir Medical Center, Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
  • Select State
    • Haifa, Select State, Israel
      • Assuta
• Netherlands
  • Nijmegen, Netherlands
    • The Radboud University Medical Center
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Johns Hopkins Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to provide written informed consent prior to any study procedures;
2. Able to communicate clearly with the Investigators and study staff;
3. Males and females aged between 18 - 90 years of age;
4. Referred and scheduled for either screening colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
5. Has not been referred to the test after positive iFOBT.

Exclusion Criteria:

1. Has a known or suspected colorectal tumor or polyp on referral;
2. Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.);
3. Has not corrected anticoagulation disorders;
4. Inability to provide informed consent;
5. Has any clinically significant condition that would, in the opinion of the investigator, preclude study participation;
6. Unable or unwilling, in the opinion of the Investigator to comply with the requirements of the protocol;
7. Employees of the investigator and study site or the sponsor, as well as family members of the employees or the investigator or the sponsor;
8. Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score (BBPS) <6 or any segment <2 (each procedure report will include the BBPS);
9. Any woman who is pregnant or potentially pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Common Colonoscopy (Group A); Patients will be examined with Conventional Colonoscopy (CC)
Experimental: Magentiq Eye Assisted Colonoscopy (Group B); Patients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC)	Procedure: Screening or Surveillance Conventionall colonoscopy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Adenoma Per Colonoscopy (APC) between the two arms	Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC)	During the Colonoscopy Procedure
Comparison of the Adenoma Per Extraction (APE) between the two arms	Compare the APE of the MEAC with the CC	During the Colonoscopy Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Adenoma Miss Rate (AMR) between the two arms	Compare the AMR of the MEAC with the CC	During the Colonoscopy Procedure
Comparison of the Adenoma Detection Rate (ADR) between the two arms	Compare the ADR of the MEAC with the CC	During the Colonoscopy Procedure

Collaborators and Investigators

• Sponsor: Magentiq Eye LTD
• Investigators: Principal Investigator: Peter Siersema, MD, Ph.D., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Adenoma Detection Rate; Adenoma Miss Rate; Screening Colonoscopy; Surveillance Colonoscopy; Automatic Polyp Detection; Adenoma Per Colonoscopy; Adenoma Per Extraction
• Other Study ID Numbers: CL-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No