Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

NCT04858477 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: 20-01268
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (5)

• Difference in polyp measurement between visual assessment and using Napoleon in fellows

  6 months

• Difference in accuracy of polyp measurement among fellow years

  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

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

  6 months

Study Arms (1)

Colonoscopy Patients + their Gastroenterology Fellows

OTHER

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.

Other: Visual estimation of polyp size; Device: Napoleon measurement of polyp size

Interventions

Visual estimation of polyp size OTHER

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

Colonoscopy Patients + their Gastroenterology Fellows

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.

Colonoscopy Patients + their Gastroenterology Fellows

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• NYU gastroenterology fellow
• Willingness and ability to provide informed consent
• \. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (4)

NYU Langone Hospital Brooklyn

Brooklyn, New York, 11220, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Manhattan VA Medical Center

New York, New York, 10016, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Renee Williams, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 26, 2021
• Study Start: June 14, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• Access Criteria: Requests may be directed to: Renee.Williams@nyulangone.org

Locations

US (4)