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

• ClinicalTrials.gov Identifier: NCT04640792
• Recruitment Status: Recruiting
• First Posted: November 23, 2020
• Last Update Posted: February 9, 2021
• Sponsor: Magentiq Eye LTD
• Information provided by (Responsible Party): Magentiq Eye LTD

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Screening Colonoscopy; Surveillance Colonoscopy	Procedure: Screening or Surveillance Conventionall colonoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 952 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: 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
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Comparison of the Adenoma Per Colonoscopy (APC) between the two arms [ Time Frame: During the Colonoscopy Procedure ]
   Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC)
2. Comparison of the Adenoma Per Extraction (APE) between the two arms [ Time Frame: During the Colonoscopy Procedure ]
   Compare the APE of the MEAC with the CC

Secondary Outcome Measures :

1. Comparison of the Adenoma Miss Rate (AMR) between the two arms [ Time Frame: During the Colonoscopy Procedure ]
   Compare the AMR of the MEAC with the CC
2. Comparison of the Adenoma Detection Rate (ADR) between the two arms [ Time Frame: During the Colonoscopy Procedure ]
   Compare the ADR of the MEAC with the CC

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 or surveillance colonoscopy which is scheduled every 3 to 10 years;
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.

Contacts and Locations

Contacts

Contact: Dror Zur, Ph.D.; +972-547-555922; dror@magentiq.com

Contact: Helena Grinberg, Ph.D.; +31-615-636666; lenagrin@gmail.com

Locations

United States, New York

Columbia University Irving Medical Center; Not yet recruiting

New York, New York, United States, 10032

Contact: Benjamin Lebwohl, Prof.

United States, Ohio

MetroHealth System; Not yet recruiting

Cleveland, Ohio, United States, 44109

Contact: Marc Landsman, MD

United States, Tennessee

Erlanger Health System; Recruiting

Chattanooga, Tennessee, United States, 37403

Contact: Arslan Kahloon, MD

Principal Investigator: Arslan Kahloon, MD

Germany

GastroZentrum Lippe; Not yet recruiting

Bad Salzuflen, Germany, 32105

Contact: Helmut Neumann, MD

Israel

Department of Gastroenterology, Shamir Medical Center, Israel; Recruiting

Be'er Ya'aqov, Israel

Contact: Haim Shirin, Prof

Hadassah Medical Organization; Recruiting

Jerusalem, Israel, 91120

Contact: Harold Jacob, MD

Sponsors and Collaborators

Magentiq Eye LTD

Investigators

• Principal Investigator: Harold Jacob, MD; Hadassah Medical Organization

More Information

• Responsible Party: Magentiq Eye LTD
• ClinicalTrials.gov Identifier: NCT04640792
• Other Study ID Numbers: CL-0001
• First Posted: November 23, 2020
• Last Update Posted: February 9, 2021
• Last Verified: November 2020

• 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

Keywords provided by Magentiq Eye LTD:

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