Extra Wide Field of View Lens Study (EFOV)

January 8, 2025 updated by: Pentax Medical

A Prospective Cohort Study Evaluating a Novel Colonoscope With a 230-degree Extra-wide Field of View Optics (EFOV)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany
        • RKM 740 Interdisciplinary Care Clinic - Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cecal Intubation Rate
Time Frame: Day 1
The proportion of procedures in which the cecum was reached.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: Day 1
Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time.
Day 1
Ileum Intubation Rate
Time Frame: Day 1
Success rate of reaching the Ileum.
Day 1
Therapeutic Intervention Success Rate
Time Frame: Day 1
The ability to collect a biopsy or remove a polyp.
Day 1
Mean number of polyps per coloscopy and its detection rate
Time Frame: Day 1
Count of number of polyps seen during colonoscopy
Day 1
Mean number of adenomas and its detection rate
Time Frame: Day 14
Count of number of adenomas/sessile serrate lesions defined by pathology
Day 14
Mean number of sessile serrate lesions and its detection rate
Time Frame: Day 14
Count of number of adenomas/sessile serrate lesions defined by pathology
Day 14
Patient Satisfaction Survey
Time Frame: 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.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pentax Medical

Investigators

  • Principal Investigator: Horst Neuhaus, MD, PhD, RKM 740 Interdisciplinary Specialist Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Actual)

December 8, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-PE-EFOV-2024-001 - V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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