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Comparison of Colonoscopy Adenoma Detection Yield

NCT05158725 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1320

Last updated 2021-12-15

No results posted yet for this study

Summary

A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.

Conditions

  • Adenoma Colon

Interventions

DEVICE

Standard Colonoscopy

In this arm, subjects will undergo colonoscopy using a standard colonoscope

DEVICE

Discovery aided colonoscopy

the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.

DEVICE

Discovery and G-EYE

The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery

Sponsors & Collaborators

  • Dr. Horst Schmidt Klinik GmbH

    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

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-05-31
Completion
2022-06-30

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 NCT05158725 on ClinicalTrials.gov