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

Sponsor

Smart Medical Systems Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05237310

Collaborator

Fujifilm (Industry)

372

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

53.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Adenoma	Device: Standard Colonoscopy Device: G-EYE Colonoscopy Device: CAD-EYE	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

372 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2: Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: 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). Group B2: 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).Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2:Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: 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). Group B2: 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).

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Feb 2, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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: 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
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: 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

Outcome Measures

Primary Outcome Measures

Additional Adenoma Detection [Upon histology results (up to 30 days)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Screening and surveillance population for Adenoma and CRC.
Subjects age is at least 18 years
The patient must understand and sign a written informed consent for the procedure.

Exclusion Criteria:

Subjects with inflammatory bowel disease;
Subjects with a personal history of hereditary polyposis syndrome;
Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
Subjects with diverticulitis or toxic megacolon;
Subjects with prior colonic surgery (exclusion appendectomy)
Subjects with a history of radiation therapy to abdomen or pelvis;
Pregnant or lactating female subjects;
Subjects who are currently enrolled in another clinical investigation.
Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Any patient condition deemed too risky for the study by the investigator