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New device aims to sharpen polyp measurements for trainee doctors

NCT ID NCT04858477

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called Napoleon to help gastroenterology fellows measure colon polyps more accurately during colonoscopies. 46 patients aged 45 and older participated. The goal was to see if using the device improves measurement accuracy compared to just looking, which could lead to better follow-up recommendations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

46 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

polyp of colon

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colonic polyp

Contacts and locations

Locations

  • Bellevue Hospital Center

    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

  • NYU Langone Hospital Brooklyn

    Brooklyn, New York, 11220, United States

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