Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®

Helio's Health

Status: Completed

Conditions: Adenoma; Colorectal Cancer

Treatments: Device: ENDOCUFF VISION® device; Device: G-EYE® colonoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT04708951

ENDOCUFF vs. G-EYE

Details and patient eligibility

About

The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.

Full description

This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.

Enrollment: 970 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Screening and surveillance population for Adenoma and CRC.
2. 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: Parallel Assignment

Masking: None (Open label)

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970 participants in 2 patient groups

ECV colonoscopy

Active Comparator group

Description:

EndoCuff Vision® device (ECV)

Treatment:

Device: ENDOCUFF VISION® device

G-EYE® colonoscopy

Experimental group

Description:

G-EYE® colonoscope (G-EYE)

Treatment:

Device: G-EYE® colonoscope