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NCT04858477 · ClinicalTrials.gov registry record · Early Phase 1
Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
A Early Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 46
- Enrollment target
NCT04858477 is a Early Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 46 participants.
The verdict
NCT04858477, a Early Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 46 participants
- Enrollment target
Study 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.
Interventions
- OTHER Visual estimation of polyp size
- DEVICE Napoleon measurement of polyp size
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2023-09-26 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04858477
The ClinicalTrials.gov registry entry for NCT04858477 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Visual estimation of polyp size is the first listed.
NCT04858477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04858477 about?
NCT04858477 is a clinical study titled "Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows". 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 an...
What is the current status of trial NCT04858477?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 46 participants. The study started on 2021-06-14. Estimated completion is 2023-09-26.
What interventions are being tested in trial NCT04858477?
The interventions under investigation include: Visual estimation of polyp size (OTHER), Napoleon measurement of polyp size (DEVICE).
Who is sponsoring clinical trial NCT04858477?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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