Extra Wide Field of View Lens Study (EFOV)

Pentax Medical

Status: Active, not recruiting

Conditions: Colonic Polyp

Treatments: Device: EFOV Colonoscope

Study type: Observational

Funder types: Industry

Identifiers

NCT06483503

CA-PE-EFOV-2024-001 - V1.0

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.