Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

NYU Langone Health

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Colonic Polyp

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04858477

20-01268

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Colonoscopy Patients + their Gastroenterology Fellows

Other group

Description:

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.

Treatment:

Other: Visual estimation of polyp size

Device: Napoleon measurement of polyp size