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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Colorectal Cancer Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

Standard Colonoscopy using a standard Fujifilm colonoscope

CAD-EYE

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

Standard Colonoscopy using a standard Fujifilm colonoscope

CAD-EYE

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

Standard Colonoscopy using a standard Fujifilm colonoscope

G-EYE Colonoscopy

Intervention Type DEVICE

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

CAD-EYE

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

Standard Colonoscopy using a standard Fujifilm colonoscope

G-EYE Colonoscopy

Intervention Type DEVICE

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

CAD-EYE

Intervention Type DEVICE

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

Interventions

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Standard Colonoscopy

Standard Colonoscopy using a standard Fujifilm colonoscope

Intervention Type DEVICE

G-EYE Colonoscopy

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

Intervention Type DEVICE

CAD-EYE

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes