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

Conditions

• Screening Colonoscopy
• Surveillance Colonoscopy

Eligibility Criteria

Sex

ALL

Age

45 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• MAGENTIQ-COLO. — DIAGNOSTIC_TEST
  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.

Study Details

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

Key Dates

Start date

Sep 15, 2024

Status verified

Aug 2024

Primary completion

Aug 31, 2025

Completion

Aug 31, 2025

Study Design

Enrollment

330 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

• Other: Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology.
  Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO.

Primary Outcome Measure

The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard. [ Time Frame: During the Colonoscopy Procedure ]

Central Contacts

• Dror Zur, Ph.D
  +972 547 555922
  [email protected]
• Tal Yerushalmi, MHA
  +972 50 2936610
  [email protected]

Locations (2)

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