Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

Colonic Polyp Clinical Trial

Official title:

Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858477
• Other study ID #: 20-01268
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 14, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Renee Williams, MD
• Phone: 646-501-4116
• Email: Renee.Williams[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Other:
• Visual estimation of polyp size
For each colonoscopy, a fellow will first visually estimate the polyp size
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in polyp measurement between visual assessment and using Napoleon in fellows		6 months
Primary	Difference in accuracy of polyp measurement among fellow years		6 months
Primary	Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon		6 months
Primary	Difference in polyp measurement between histology and using Napoleon		6 months
Primary	Proportion of cases with a difference in the recommended surveillance interval based on polyp size		6 months