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

NCT ID: NCT04640792

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 952 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-02-10

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.

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.

Conditions

Screening Colonoscopy; Surveillance Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Common Colonoscopy (Group A)

Patients will be examined with Conventional Colonoscopy (CC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Magentiq Eye Assisted Colonoscopy (Group B)

Patients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC)

Group Type: EXPERIMENTAL

Screening or Surveillance Conventionall colonoscopy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Magentiq Eye LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Siersema, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Columbia University Irving Medical Center

New York, New York, United States

MetroHealth System

Cleveland, Ohio, United States

Erlanger Health System

Chattanooga, Tennessee, United States

GastroZentrum Lippe

Bad Salzuflen, , 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, , Israel

The Radboud University Medical Center

Nijmegen, , Netherlands

Countries

United States; Germany; Israel; Netherlands

References

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.

Reference Type: DERIVED

PMID: 38395537 (View on PubMed)

Other Identifiers

CL-0001

Identifier Type: -

Identifier Source: org_study_id