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

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

Tracking Information
First Submitted Date  ICMJE November 13, 2020
First Posted Date  ICMJE November 23, 2020
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Screening Colonoscopy
  • Surveillance Colonoscopy
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: Screening or Surveillance Conventionall colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2020)
952
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dror Zur, Ph.D. +972-547-555922 dror@magentiq.com
Contact: Helena Grinberg, Ph.D. +31-615-636666 lenagrin@gmail.com
Listed Location Countries  ICMJE Germany,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04640792
Other Study ID Numbers  ICMJE CL-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Magentiq Eye LTD
Study Sponsor  ICMJE Magentiq Eye LTD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harold Jacob, MD Hadassah Medical Organization
PRS Account Magentiq Eye LTD
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP