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

Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Adenoma
• Intervention / Treatment: Device: Standard Colonoscopy; Device: CAD-EYE; Device: G-EYE Colonoscopy

Detailed Description

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
• Enrollment (Anticipated): 372
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralf Kiesslich, Prof.; Phone Number: +49 611 43-9002; Email: Ralf.Kiesslich@helios-gesundheit.de

Study Locations

• Germany
  • Wiesbaden, Germany, 65199
    • Recruiting
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
    • Contact: Ralf Kiesslich, Prof.; Phone Number: +49 611 43-9002; Email: Ralf.Kiesslich@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Colonoscopy followed by CAD-EYE; Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).	Device: Standard Colonoscopy; Standard Colonoscopy using a standard Fujifilm colonoscope; Device: CAD-EYE; Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Active Comparator: CAD-EYE followed by Standard Colonoscopy; Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).	Device: Standard Colonoscopy; Standard Colonoscopy using a standard Fujifilm colonoscope; Device: CAD-EYE; Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
Active Comparator: Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy; Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).	Device: Standard Colonoscopy; Standard Colonoscopy using a standard Fujifilm colonoscope; Device: CAD-EYE; Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence; Device: G-EYE Colonoscopy; G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
Active Comparator: Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy; Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).	Device: Standard Colonoscopy; Standard Colonoscopy using a standard Fujifilm colonoscope; Device: CAD-EYE; Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence; Device: G-EYE Colonoscopy; G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Upon histology results (up to 30 days)

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Collaborators: Fujifilm
• Investigators: Principal Investigator: Ralf Kiesslich, Prof., Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colonoscopy; Adenoma; G-EYE; CAD-EYE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: G-EYE 15076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No