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

Smart Medical Systems Ltd.372 enrolled

Overview

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. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

372

Conditions

Colorectal Cancer Adenoma

Interventions

Standard ColonoscopyDEVICE

Standard Colonoscopy using a standard Fujifilm colonoscope

G-EYE ColonoscopyDEVICE

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

CAD-EYEDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Screening and surveillance population for Adenoma and CRC. 2. Subjects age is at least 18 years 3. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of hereditary polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with prior colonic surgery (exclusion appendectomy) 6. Subjects with a history of radiation therapy to abdomen or pelvis; 7. Pregnant or lactating female subjects; 8. Subjects who are currently enrolled in another clinical investigation. 9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 11. Any patient condition deemed too risky for the study by the investigator

Locations (1)

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Wiesbaden, Germany

RECRUITING

Outcomes

Primary Outcomes

Additional Adenoma Detection

Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy

Time frame: Upon histology results (up to 30 days)

Central Contacts

Ralf Kiesslich, Prof.

CONTACT

+49 611 43-9002 Ralf.Kiesslich@helios-gesundheit.de

Data from ClinicalTrials.gov

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