Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

• Sponsor: NYU Langone Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04858477
• Collaborator: (none)
• Enrollment: 150
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 23.6
• Patients Per Site: 37.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp	Other: Visual estimation of polyp size; Other: Napoleon measurement of polyp size	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
• Actual Study Start Date: Jun 14, 2021
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Difference in polyp measurement between visual assessment and using Napoleon in fellows [6 months]

2. Difference in accuracy of polyp measurement among fellow years [6 months]

3. Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon [6 months]

4. Difference in polyp measurement between histology and using Napoleon [6 months]

5. Proportion of cases with a difference in the recommended surveillance interval based on polyp size [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Hospital Brooklyn	Brooklyn	New York	United States	11220
2	Bellevue Hospital Center	New York	New York	United States	10016
3	Manhattan VA Medical Center	New York	New York	United States	10016
4	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04858477
• Other Study ID Numbers: 20-01268
• First Posted: Apr 26, 2021
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Polyps; Colonic Polyps

Study Results

No Results Posted as of May 11, 2022