Clinical trial NCT04858477: Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
Official title: Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Colonic Polyp
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Difference in polyp measurement between visual assessment and using Napoleon in fellows
timeFrame: 6 months
measure: Difference in accuracy of polyp measurement among fellow years
timeFrame: 6 months
measure: Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon
timeFrame: 6 months
measure: Difference in polyp measurement between histology and using Napoleon
timeFrame: 6 months
measure: Proportion of cases with a difference in the recommended surveillance interval based on polyp size
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Langone Hospital Brooklyn
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: Manhattan VA Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Renee Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: