Extra Wide Field of View Lens Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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EFOV Colonoscope

Routine colonoscopy using the EFOV lens in the colonoscope.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes