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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy Patients + their Gastroenterology Fellows | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual estimation of polyp size | Other | For each colonoscopy, a fellow will first visually estimate the polyp size |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in polyp measurement between visual assessment and using Napoleon in fellows | 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 | |
| Proportion of cases with a difference in the recommended surveillance interval based on polyp size | 6 months |
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Patients:
Inclusion Criteria:
Exclusion Criteria:
An individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study:
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:
Exclusion Criteria:
1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending
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| Name | Affiliation | Role |
|---|---|---|
| Renee Williams, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Hospital Brooklyn | Brooklyn | New York | 11220 | United States | ||
| Bellevue Hospital Center |
be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Renee.Williams@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
Requests may be directed to: Renee.Williams@nyulangone.org
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Napoleon measurement of polyp size | 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. |
|
| New York |
| New York |
| 10016 |
| United States |
| Manhattan VA Medical Center | New York | New York | 10016 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |