Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy

NCT05237310 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2022-03-08

No results posted yet for this study

Summary

The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.

Conditions

Interventions

DEVICE

Standard Colonoscopy

Standard Colonoscopy using a standard Fujifilm colonoscope

DEVICE

G-EYE Colonoscopy

G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope

DEVICE

CAD-EYE

Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence

Sponsors & Collaborators

  • Fujifilm

    collaborator INDUSTRY
  • Smart Medical Systems Ltd.

    lead INDUSTRY

Principal Investigators

  • Ralf Kiesslich, Prof. · Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2022-08-31
Completion
2022-09-30

Countries

  • Germany

Study Locations

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Entities

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 NCT05237310 on ClinicalTrials.gov