NCT04858477

Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Visual estimation of polyp size	For each colonoscopy, a fellow will first visually estimate the polyp size
DEVICE	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.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-09-26
• Completion: 2023-09-26
• First posted: 2021-04-26
• Last updated: 2026-02-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study