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

Smart Medical Systems

Status: Unknown

Conditions: Adenoma; Colorectal Cancer

Treatments: Device: CAD-EYE; Device: Standard Colonoscopy; Device: G-EYE Colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05237310

G-EYE 15076

Details and patient eligibility

About

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.

Full 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

Enrollment: 372 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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372 participants in 4 patient groups

Standard Colonoscopy followed by CAD-EYE

Active Comparator group

Description:

Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Treatment:

Device: CAD-EYE

Device: Standard Colonoscopy

CAD-EYE followed by Standard Colonoscopy

Active Comparator group

Description:

Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Treatment:

Device: CAD-EYE

Device: Standard Colonoscopy

Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

Active Comparator group

Description:

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).

Treatment:

Device: G-EYE Colonoscopy

Device: CAD-EYE

Device: Standard Colonoscopy

Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy

Active Comparator group

Description:

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).

Treatment:

Device: G-EYE Colonoscopy

Device: CAD-EYE

Device: Standard Colonoscopy