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.

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp
• Intervention / Treatment: Other: Visual estimation of polyp size; Other: Napoleon measurement of polyp size

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Renee Williams, MD; Phone Number: 646-501-4116; Email: Renee.Williams@nyulangone.org
• Study Contact Backup: Name: Matthew O'Mara, MD; Email: Matthew.Omara@nyulangone.org

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11220
      • Recruiting
      • NYU Langone Hospital Brooklyn
      • Contact: Adam Goodman, MD
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Renee Williams, MD
    • New York, New York, United States, 10016
      • Recruiting
      • Bellevue Hospital Center
      • Contact: Renee Williams, MD
    • New York, New York, United States, 10016
      • Recruiting
      • Manhattan VA Medical Center
      • Contact: Violeta Popov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Patients:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Colonoscopy Patients + their Gastroenterology Fellows; 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; For each colonoscopy, a fellow will first visually estimate the polyp size; Other: Napoleon measurement of polyp size; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Renee Williams, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: 20-01268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Renee.Williams@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing 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
• IPD Sharing Access Criteria: Requests may be directed to: Renee.Williams@nyulangone.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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.: Yes