Status:
UNKNOWN
A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE
Lead Sponsor:
Dr. Horst Schmidt Klinik GmbH
Conditions:
Adenoma
Colo-rectal Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering an...
Detailed Description
Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering an...
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 :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT05318495
Start Date
March 1 2022
End Date
December 1 2022
Last Update
April 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Helios Dr. Horst Schmidt Kliniken
Wiesbaden, Germany, 65199