Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Smart Medical Systems

Status: Completed

Conditions: Polyps; Adenoma; Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01917513

G-EYE 15505

Details and patient eligibility

About

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

The study will enroll 1000 subjects. 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.

Subjects will sign informed consent form and undergo randomization. The study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the G-EYE™ endoscope.

Enrollment: 1,000 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 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
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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1,000 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