G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist

Launched by SMART MEDICAL SYSTEMS LTD. · Feb 16, 2014

Keywords

ClinConnect Summary

Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.

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)