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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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640792


Contacts
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Contact: Dror Zur, Ph.D. +972-547-555922 dror@magentiq.com
Contact: Helena Grinberg, Ph.D. +31-615-636666 lenagrin@gmail.com

Locations
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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
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Principal Investigator: Harold Jacob, MD Hadassah Medical Organization
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Responsible Party: Magentiq Eye LTD
ClinicalTrials.gov Identifier: NCT04640792    
Other Study ID Numbers: CL-0001
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: November 2020

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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