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
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
- Colorectal Cancer
- Adenoma
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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