Colonic PolypEarly Phase 1NCT04858477
Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
A Early Phase 1 study testing Visual estimation of polyp size and Napoleon measurement of polyp size in people with Colonic Polyp, run by NYU Langone Health at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Visual estimation of polyp size and Napoleon measurement of polyp size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jun 2021to 26 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age 45 and above
- Undergoing a colonoscopy performed by a gastroenterology fellow
- Willingness and ability to provide informed consent
- NYU gastroenterology fellow
- Willingness and ability to provide informed consent
Who cannot join
- History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
- 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:
- Colonoscopy without polyps
- Polyps not removed in entirety
- Polyps with indeterminate size
Show all 10Show fewer
- 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
- 1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NYU Langone Hospital Brooklyn
Brooklyn, New York, 11220
Bellevue Hospital Center
New York, New York, 10016
Manhattan VA Medical Center
New York, New York, 10016
NYU Langone Health
New York, New York, 10016
About this study
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
- Being tested
- Visual estimation of polyp size, Napoleon measurement of polyp size
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual estimation of polyp sizeOther
For each colonoscopy, a fellow will first visually estimate the polyp size
Napoleon measurement of polyp sizeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Visual estimation of polyp size; Device: Napoleon measurement of polyp size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in polyp measurement between visual assessment and using Napoleon in fellows
Measured: 6 months
Difference in accuracy of polyp measurement among fellow years
Measured: 6 months
Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon
Measured: 6 months
Difference in polyp measurement between histology and using Napoleon
Measured: 6 months
Proportion of cases with a difference in the recommended surveillance interval based on polyp size
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start14 Jun 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renee Williams, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858477
- Sponsor's protocol ID
- 20-01268
- Status last verified
- Feb 2026
- First submitted
- 20 Apr 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
- ClinicalTrials.gov ID
- NCT04858477
- Acronym / sponsor ID
- 20-01268
- Conditions
- Colonic Polyp
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy Patients + their Gastroenterology Fellows | Other | Other: Visual estimation of polyp size, Device: Napoleon measurement of polyp sizeInpatient 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult age 45 and above
- Undergoing a colonoscopy performed by a gastroenterology fellow
- Willingness and ability to provide informed consent
- NYU gastroenterology fellow
- Willingness and ability to provide informed consent
Key exclusion criteria (10 listed)
- History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
- 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:
- Colonoscopy without polyps
- Polyps not removed in entirety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual estimation of polyp sizeFor each colonoscopy, a fellow will first visually estimate the polyp size | Other | Colonoscopy Patients + their Gastroenterology Fellows |
| Napoleon measurement of polyp sizeFor 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. | Device | Colonoscopy Patients + their Gastroenterology Fellows |
Primary outcome
Difference in polyp measurement between visual assessment and using Napoleon in fellows
Time frame: 6 months
Difference in accuracy of polyp measurement among fellow years
Time frame: 6 months
Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon
Time frame: 6 months
Difference in polyp measurement between histology and using Napoleon
Time frame: 6 months
Proportion of cases with a difference in the recommended surveillance interval based on polyp size
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Williams, MD principal investigator
NYU Langone Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Visual estimation of polyp size and Napoleon measurement of polyp size in people with Colonic Polyp, run by NYU Langone Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in polyp measurement between visual assessment and using Napoleon in fellows (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.