Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy

Smart Medical Systems

Status: Unknown

Conditions: Polyps; Adenoma; Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545699

G-EYE 15507

Details and patient eligibility

About

The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.

Full description

This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.

The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.

Subjects will sign an informed consent form and undergo randomization.

Enrollment: 350 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients over 50 years old
2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits, for diagnostic evaluation or for surveillance colonoscopy (history of adenoma resection).
3. The patient must understand and provide written consent for the procedure.

Exclusion criteria

1. Subjects with inflammatory bowel disease;
2. Subjects with a personal history of polyposis syndrome;
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
4. Subjects with diverticulitis or toxic megacolon;
5. Subjects with a history of radiation therapy to abdomen or pelvis;
6. Pregnant or lactating female subjects;
7. Subjects who are currently enrolled in another clinical investigation.
8. Subjects with current oral or parenteral use of anticoagulants that have not stopped using anticoagulants as required by the guidelines of the medical center;
9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
10. Any patient condition deemed too risky for the study by the investigator
11. Previous colonic surgery (except for appendectomy)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

G-EYE™ Colonoscopy

Experimental group

Description:

G-EYE™ Colonoscopy

Treatment:

Device: G-EYE™ Colonoscopy

Standard Colonoscopy

Active Comparator group

Description:

Standard Colonoscopy

Treatment:

Device: Standard Colonoscopy