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
1 other identifier
interventional
952
4 countries
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedMay 5, 2022
March 1, 2022
1.4 years
November 13, 2020
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Comparison of the Adenoma Miss Rate (AMR) between the two arms
During the Colonoscopy Procedure
Comparison of the Adenoma Detection Rate (ADR) between the two arms
During the Colonoscopy Procedure
Study Arms (2)
Common Colonoscopy (Group A)
NO INTERVENTIONPatients will be examined with Conventional Colonoscopy (CC)
Magentiq Eye Assisted Colonoscopy (Group B)
EXPERIMENTALPatients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC)
Interventions
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
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent prior to any study procedures;
- Able to communicate clearly with the Investigators and study staff;
- Males and females aged between 18 - 90 years of age;
- Referred and scheduled for either screening colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
- Has not been referred to the test after positive iFOBT.
You may not qualify if:
- Has a known or suspected colorectal tumor or polyp on referral;
- Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.);
- Has not corrected anticoagulation disorders;
- Inability to provide informed consent;
- Has any clinically significant condition that would, in the opinion of the investigator, preclude study participation;
- Unable or unwilling, in the opinion of the Investigator to comply with the requirements of the protocol;
- Employees of the investigator and study site or the sponsor, as well as family members of the employees or the investigator or the sponsor;
- Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score (BBPS) \<6 or any segment \<2 (each procedure report will include the BBPS);
- Any woman who is pregnant or potentially pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Magentiq Eye LTDlead
Study Sites (11)
Johns Hopkins Hospital
Baltimore, Maryland, 21202, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
MetroHealth System
Cleveland, Ohio, 44109, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
GastroZentrum Lippe
Bad Salzuflen, 32105, Germany
Mainz University Medical Center
Mainz, Germany
Assuta
Haifa, Select State, Israel
Department of Gastroenterology, Shamir Medical Center, Israel
Be’er Ya‘aqov, Israel
Shamir Medical Center
Be’er Ya‘aqov, Israel
Hadassah Medical Organization
Jerusalem, 91120, Israel
The Radboud University Medical Center
Nijmegen, Netherlands
Related Publications (1)
Maas MHJ, Neumann H, Shirin H, Katz LH, Benson AA, Kahloon A, Soons E, Hazzan R, Landsman MJ, Lebwohl B, Lewis SK, Sivanathan V, Ngamruengphong S, Jacob H, Siersema PD. A computer-aided polyp detection system in screening and surveillance colonoscopy: an international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar;6(3):e157-e165. doi: 10.1016/S2589-7500(23)00242-X.
PMID: 38395537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Siersema, MD, Ph.D.
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 23, 2020
Study Start
October 1, 2020
Primary Completion
February 10, 2022
Study Completion
February 10, 2022
Last Updated
May 5, 2022
Record last verified: 2022-03