Extra Wide Field of View Lens Study

Active, not recruiting

• Conditions: Colonic Polyp

• Registration Number: NCT06483503
• Lead Sponsor: Pentax Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-03
• Study Start: 2024-08-21
• Primary Completion: 2024-12-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 ≥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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cecal Intubation Rate	Day 1	The proportion of procedures in which the cecum was reached.

Secondary Outcome Measures

Name	Time	Method
Mean number of polyps per coloscopy and its detection rate	Day 1	Count of number of polyps seen during colonoscopy
Mean number of adenomas and its detection rate	Day 14	Count of number of adenomas/sessile serrate lesions defined by pathology
Procedure Time	Day 1	Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time.
Ileum Intubation Rate	Day 1	Success rate of reaching the Ileum.
Mean number of sessile serrate lesions and its detection rate	Day 14	Count of number of adenomas/sessile serrate lesions defined by pathology
Therapeutic Intervention Success Rate	Day 1	The ability to collect a biopsy or remove a polyp.
Patient Satisfaction Survey	Day 14	During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure.

Trial Locations

Locations (1)

RKM 740 Interdisciplinary Care Clinic - Gastroenterology; 🇩🇪 Düsseldorf, Germany