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A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE

NCT05318495 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2022-04-08

No results posted yet for this study

Summary

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:

1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Conditions

  • Adenoma
  • Colo-rectal Cancer

Interventions

DEVICE

Standard Colonoscopy

The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).

DEVICE

CAD-EYE

CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.

DEVICE

G-EYE

The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

Sponsors & Collaborators

  • Dr. Horst Schmidt Klinik GmbH

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Germany

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 NCT05318495 on ClinicalTrials.gov