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Completed

NCT Number: NCT04858477

Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

This is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a Micro-Tech Endoscopic Polyp Measurement Device named Napoleon. The study will evaluate the feasibility of Napoleon as a polyp measurement device. Investigators will collect data on inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from May 2021 - May 2022 for 150 patients. Investigators will include all colonoscopies with polyps done in adults age 45 and above. For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. Investigators will calculate the difference in polyp measurement between visual assessment and using Napoleon for each fellow year and compare differences among fellow years. Investigators will evaluate for changes in fellows' accuracy of polyp measurement with subsequent uses of Napoleon. Investigators will determine the proportion of cases with a change in the recommended surveillance interval based on polyp size. A survey will be given to all fellows to assess the level of ease with using Napoleon.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NYU Langone Hospital Brooklyn, Brooklyn, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Patients:

Inclusion criteria

  • Adult age 45 and above
  • Undergoing a colonoscopy performed by a gastroenterology fellow
  • Willingness and ability to provide informed consent

Exclusion criteria

  • History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
  • Undergoing a diagnostic colonoscopy for inflammatory bowel disease or other known inflammatory/infectious process

An individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study:

  • Colonoscopy without polyps
  • Polyps not removed in entirety
  • Polyps with indeterminate size

An individual who meets any of the following criteria after the colonoscopy will be excluded from participation in this study:

  • Hyperplastic or non-adenomatous polyps on pathology report

Fellows

Inclusion criteria

  • NYU gastroenterology fellow
  • Willingness and ability to provide informed consent

Exclusion criteria

  • Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending

Treatment and study plan

Visual estimation of polyp size

Other

For each colonoscopy, a fellow will first visually estimate the polyp size

Napoleon measurement of polyp size

Device

For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. The Micro-Tech Endoscopic Polyp Measurement Device named Napoleon is a small catheter with a 15mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA.

Primary outcomes

  1. Difference in polyp measurement between visual assessment and using Napoleon in fellows

    Time frame: 6 months

  2. Difference in accuracy of polyp measurement among fellow years

    Time frame: 6 months

  3. Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon

    Time frame: 6 months

  4. Difference in polyp measurement between histology and using Napoleon

    Time frame: 6 months

  5. Proportion of cases with a difference in the recommended surveillance interval based on polyp size

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2021
Registry last updated
Feb 25, 2026

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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