Status:
COMPLETED
Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®
Lead Sponsor:
Dr. Horst Schmidt Klinik GmbH
Conditions:
Adenoma
Colorectal Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV 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
- Screening and surveillance population for Adenoma and CRC.
- The patient must understand and sign a written informed consent for the procedure.
Exclusion
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of hereditary polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with prior colonic surgery (exclusion appendectomy)
- 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, not considered eligible by the investigator.
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
970 Patients enrolled
Trial Details
Trial ID
NCT04708951
Start Date
January 1 2021
End Date
October 15 2021
Last Update
October 22 2021
Active Locations (3)
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1
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
2
NYU Langone Health
New York, New York, United States, 10016
3
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, Germany, 65199