Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

Early Phase 1

Active, not recruiting

• Conditions: Colonic Polyp
• Interventions: Other: Visual estimation of polyp size; Other: Napoleon measurement of polyp size

• Registration Number: NCT04858477
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-26
• Study Start: 2021-06-14
• Primary Completion: 2023-09-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-20
• Study Completion: 2025-09-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Adult age 45 and above
2. Undergoing a colonoscopy performed by a gastroenterology fellow
3. Willingness and ability to provide informed consent

Exclusion Criteria

1. History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
2. 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:

1. Colonoscopy without polyps
2. Polyps not removed in entirety
3. Polyps with indeterminate size

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

1. Hyperplastic or non-adenomatous polyps on pathology report

Fellows

Inclusion Criteria:

1. NYU gastroenterology fellow
2. Willingness and ability to provide informed consent

Exclusion Criteria:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonoscopy Patients + their Gastroenterology Fellows	Napoleon measurement of polyp size	Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.
Colonoscopy Patients + their Gastroenterology Fellows	Visual estimation of polyp size	Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.

Primary Outcome Measures

Name	Time	Method
Difference in accuracy of polyp measurement among fellow years	6 months
Proportion of cases with a difference in the recommended surveillance interval based on polyp size	6 months
Difference in polyp measurement between visual assessment and using Napoleon in fellows	6 months
Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon	6 months
Difference in polyp measurement between histology and using Napoleon	6 months

Trial Locations

Locations (4)

NYU Langone Hospital Brooklyn; 🇺🇸 Brooklyn, New York, United States

Bellevue Hospital Center; 🇺🇸 New York, New York, United States

Manhattan VA Medical Center; 🇺🇸 New York, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States