Status:
COMPLETED
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Lead Sponsor:
Smart Medical Systems Ltd.
Conditions:
Adenoma
Polyps
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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
Detailed 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 perform...
Eligibility Criteria
Inclusion
- Patients over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
- The patient must understand and provide written consent for the procedure.
Exclusion
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with a history of radiation therapy to abdomen or pelvis;
- Pregnant or lactating female subjects;
- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01917513
Start Date
May 1 2014
End Date
September 1 2016
Last Update
January 23 2018
Active Locations (15)
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1
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02115
2
NYU Langone Medical Center
New York, New York, United States, 10016
3
Herlev Hospital
Harlev, Denmark, 2730
4
Universitätsmedizin Johannes Gutenberg University Mainz
Mainz, Germany, 55131