Colonic Polyp
Conditions
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.
Interventions
OTHERVisual estimation of polyp size
For each colonoscopy, a fellow will first visually estimate the polyp size
DEVICENapoleon 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of cases with a difference in the recommended surveillance interval based on polyp size | 6 months |
| Difference in accuracy of polyp measurement among fellow years | 6 months |
| Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon | 6 months |
| Difference in polyp measurement between histology and using Napoleon | 6 months |
| Difference in polyp measurement between visual assessment and using Napoleon in fellows | 6 months |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRenee Williams, MD
NYU Langone Health
Outcome results
None listed