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OpenTrials
Active, Not Recruiting

NCT Number: NCT06483503

Extra Wide Field of View Lens Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RKM 740 Interdisciplinary Care Clinic - Gastroenterology

Düsseldorf, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EFOV Colonoscope

Device

Routine colonoscopy using the EFOV lens in the colonoscope.

Primary outcomes

  1. Cecal Intubation Rate

    Time frame: Day 1

    The proportion of procedures in which the cecum was reached.

Secondary outcomes

  1. Procedure Time

    Time frame: Day 1

    Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time.

  2. Ileum Intubation Rate

    Time frame: Day 1

    Success rate of reaching the Ileum.

  3. Therapeutic Intervention Success Rate

    Time frame: Day 1

    The ability to collect a biopsy or remove a polyp.

  4. Mean number of polyps per coloscopy and its detection rate

    Time frame: Day 1

    Count of number of polyps seen during colonoscopy

  5. Mean number of adenomas and its detection rate

    Time frame: Day 14

    Count of number of adenomas/sessile serrate lesions defined by pathology

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Pentax Medical

Industry

Registry information

Official study title

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

Acronym: EFOV

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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