Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Collecting Recorded Videos of Colonoscopy Screening Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891290
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Magentiq Eye LTD

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.

Condition or disease Intervention/treatment
Colon Polyp Other: Collecting recorded videos of Colonoscopy screening tests of the general population

Detailed Description:

Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.

Secondary objectives

• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collecting Recorded Videos of Colonoscopy Screening Tests for the Evaluation of the Automatic Polyp Detection System (APDS) Medical Device
Actual Study Start Date : November 21, 2016
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Collecting recorded videos of Colonoscopy screening tests of the general population
    To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality. [ Time Frame: Half an hour from the end of the procedure at which the video was recorded. ]
    Each recorded video is visually inspected immediately at the end of the procedure by an experienced team member who rates it with a number between 1 (low quality) to 10 (high quality). Only videos with rate above 7 are considered as having sufficient high quality.

  2. De-Identified procedure report which was visually inspected to verify that it includes all the needed details about the polyps that were detected during the procedure. [ Time Frame: Half an hour from the end of the procedure for which the procedure report was filled-in. ]
    Each de-Identified procedure report is visually inspected immediately at the end of the procedure by an experienced team member who gives it binary score (0 or 1), 1 if it includes all the needed details about the polyps that were detected during the procedure, and 0 if it does not include all the needed details about the polyps that were detected during the procedure.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects shall be recruited by the investigator from within the investigator's patient population of colonoscopy. In this study one site will participate and enroll up to 300 subjects according to the inclusion/exclusion criteria. Each subject (up to 300 subjects) included will pass one regular colonoscopy screening test which will be recorded in the way which is described above.

Enrolled subjects that did not complete the full course of the study will be replaced.

Criteria

Inclusion Criteria:

Subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the Gastroenterolgy Department of the selected center. In addation, the following criteria have to be met to be eligible for the study:

  1. Able to read, understand and provide written Informed Consent;
  2. Females or males - older than 18 years old

Exclusion Criteria:

Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:

  • Bleeding disorder or unacceptable risk of bleeding
  • Terminal illness or life threatening malignancy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03891290


Locations
Layout table for location information
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 3810101
Sponsors and Collaborators
Magentiq Eye LTD
Investigators
Layout table for investigator information
Principal Investigator: Yael Kopelman, MD Hillel Yaffe Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Magentiq Eye LTD
ClinicalTrials.gov Identifier: NCT03891290    
Other Study ID Numbers: 0009-16-HYMC
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyps
Pathological Conditions, Anatomical