Collecting Recorded Videos of Colonoscopy and Gastroscopy Tests for the Evaluation of the (ME-APDS).

NCT06566872 | Recruiting

• 1 other identifier: CL-0041
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The study shall mainly help to better evaluate the performance the ME-APDS device and secondly it may help the development of additional future versions of the ME-APDS. Primary endpoints

• Clear video of the colon or the stomach or the esophagus achieved during the test.
• Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial. Secondary endpoints
• A recorded video of at least 80% of the actual test duration.

Conditions

Colon Polyp

Keywords

Polyps

Outcome Measures

Primary Outcomes (2)

• To support the offline evaluation, in objective way, of the performance of the ME-APDS device by testing the sensitivity and specificity and additional statistical parameters.

  Clear video of the colon or the stomach or the esophagus achieved during the test.

  during colonoscopy and gastroscopy procedure

• Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.

  Acceptable colon or gastro test performance according to the standards, criteria, and regulations of the medical center of the trial.

  during colonoscopy and gastroscopy procedure

Secondary Outcomes (1)

• A recorded video of at least 80% of the actual test duration.

  during colonoscopy and gastroscopy procedure

Interventions

ME-APDS DEVICE

No Intervention

Also known as: Automatic Polyp Detection System (ME-APDS) Medical Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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 and Gastroscopy. In this study one site will participate and enroll not less than 250 patients and up to 700 subjects according to the inclusion/exclusion criteria. Each subject (not less than 250 patients and up to 700 subjects) included will pass one regular colonoscopy and/or gastroscopy 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. Eligibility Each subject will be evaluated by the Investigator to assess his/ her suitability for entry into this study according to the Inclusion and Exclusion criteria.

You may qualify if:

• Subjects must meet all the - criteria related to regular colonoscopy and/or gastroscopy according to the standard of care at the Gastroenterolgy Department of the selected center, \_In addition 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)

Department of Gastroenterology, Shamir Medical Center, Israel

Be’er Ya‘aqov, Israel

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Polyps

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

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

Study Officials

• Haim Shirin, Prof.

  Gastroenterology Department of Shamir Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Zur, Ph.D.

CONTACT

+972(54)7555922; dror@magentiq.com

Study Design

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

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: August 22, 2024
• Study Start: May 16, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)