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

NCT04640792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 952

Last updated 2022-05-05

No results posted yet for this study

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.

Conditions

  • Screening Colonoscopy
  • Surveillance Colonoscopy

Interventions

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

Sponsors & Collaborators

  • Magentiq Eye LTD

    lead INDUSTRY

Principal Investigators

  • Peter Siersema, MD, Ph.D. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-02-10
Completion
2022-02-10

Countries

  • United States
  • Germany
  • Israel
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640792 on ClinicalTrials.gov