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Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

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ClinicalTrials.gov Identifier: NCT04858477
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colonic Polyp Other: Visual estimation of polyp size Other: Napoleon measurement of polyp size Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Visual estimation of polyp size
For each colonoscopy, a fellow will first visually estimate the polyp size

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.


Outcome Measures
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Primary Outcome Measures :
  1. Difference in polyp measurement between visual assessment and using Napoleon in fellows [ Time Frame: 6 months ]
  2. Difference in accuracy of polyp measurement among fellow years [ Time Frame: 6 months ]
  3. Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon [ Time Frame: 6 months ]
  4. Difference in polyp measurement between histology and using Napoleon [ Time Frame: 6 months ]
  5. Proportion of cases with a difference in the recommended surveillance interval based on polyp size [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858477


Contacts
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Contact: Renee Williams, MD 646-501-4116 Renee.Williams@nyulangone.org
Contact: Sandy Ng, MD Sandy.Ng@nyulangone.org

Locations
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United States, New York
NYU Langone Hospital Brooklyn Recruiting
Brooklyn, New York, United States, 11220
Contact: Adam Goodman, MD         
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: Renee Williams, MD         
Manhattan VA Medical Center Recruiting
New York, New York, United States, 10016
Contact: Violeta Popov, MD         
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Renee Williams, MD         
Sponsors and Collaborators
NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04858477    
Other Study ID Numbers: 20-01268
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
Access Criteria: Requests may be directed to: Renee.Williams@nyulangone.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps