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Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.

NCT06568523 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-08-23

No results posted yet for this study

Summary

This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.

Conditions

  • Screening Colonoscopy
  • Surveillance Colonoscopy

Interventions

DIAGNOSTIC_TEST

MAGENTIQ-COLO.

This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.

Sponsors & Collaborators

  • Magentiq Eye LTD

    lead INDUSTRY

Principal Investigators

  • Peter Siersema, MD, Ph.D. · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Device
Yes

Countries

  • United States
  • 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 NCT06568523 on ClinicalTrials.gov