NCT06483503
Active, not recruiting
Not Applicable
A Prospective Cohort Study Evaluating a Novel Colonoscope With a 230-degree Extra-wide Field of View Optics (EFOV)
ConditionsColonic Polyp
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colonic Polyp
- Sponsor
- Pentax Medical
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Cecal Intubation Rate
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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 this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.
Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •ASA classification ≥
- •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.
Outcomes
Primary Outcomes
Cecal Intubation Rate
Time Frame: Day 1
The proportion of procedures in which the cecum was reached.
Secondary Outcomes
- Mean number of polyps per coloscopy and its detection rate(Day 1)
- Mean number of adenomas and its detection rate(Day 14)
- Procedure Time(Day 1)
- Ileum Intubation Rate(Day 1)
- Mean number of sessile serrate lesions and its detection rate(Day 14)
- Therapeutic Intervention Success Rate(Day 1)
- Patient Satisfaction Survey(Day 14)
Study Sites (1)
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