Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

NCT ID: NCT04858477

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2025-09-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Visual estimation of polyp size

Intervention Type: OTHER

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

Napoleon measurement of polyp size

Intervention Type: 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.

Interventions

Visual estimation of polyp size

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

1. NYU gastroenterology fellow

2. 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

1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renee Williams, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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, United States

Countries

United States

Other Identifiers

20-01268

Identifier Type: -

Identifier Source: org_study_id