Status:
ACTIVE_NOT_RECRUITING
Extra Wide Field of View Lens Study
Lead Sponsor:
Pentax Medical
Conditions:
Colonic Polyp
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question thi...
Eligibility Criteria
Inclusion
- Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.
- Signed informed consent.
Exclusion
- ASA classification ≥3.
- Age \<18 years.
- Known or suspicion of inflammatory bowel disease.
- Known polyp(s) for polypectomy.
- High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease.
- Prior colorectal surgery.
- Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems.
- Unable or unwilling to undergo bowel cleansing for colonoscopy.
- Female patients who are pregnant or nursing.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Key Trial Info
Start Date :
August 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06483503
Start Date
August 21 2024
End Date
March 30 2025
Last Update
January 10 2025
Active Locations (1)
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1
RKM 740 Interdisciplinary Care Clinic - Gastroenterology
Düsseldorf, Germany