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

Launched by SMART MEDICAL SYSTEMS LTD. · Aug 4, 2013

Keywords

ClinConnect Summary

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 27...

Gender

ALL

Eligibility criteria

• 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)