Collecting Recorded Videos of Colonoscopy Screening Tests

NCT03891290 | Completed

• 1 other identifier: 0009-16-HYMC
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyp

Outcome Measures

Primary Outcomes (2)

• Recorded colonoscopy video which was verified by visual inspection to have sufficient high quality.

  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.

  Half an hour from the end of the procedure at which the video was recorded.

• 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.

  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.

  Half an hour from the end of the procedure for which the procedure report was filled-in.

Interventions

Collecting recorded videos of Colonoscopy screening tests of the general population OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Bleeding disorder or unacceptable risk of bleeding
• Terminal illness or life threatening malignancy

Sponsors & Collaborators

• Magentiq Eye LTD: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 3810101, Israel

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yael Kopelman, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 27, 2019
• Study Start: November 21, 2016
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)