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NCT03856255 · ClinicalTrials.gov registry record · NA

Polyp Measurement Device

A NA study, sponsored by NYU Langone Health.

Terminated
Registry status
NA
Development phase
36
Enrollment target

NCT03856255 is a NA study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 36 participants.

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The verdict

NCT03856255, a NA study, was terminated before completion, sponsored by NYU Langone Health.

TERMINATED
Registry status
NA
Development phase
36 participants
Enrollment target

Study Summary

Colorectal cancer is the second-leading cause of cancer death in the United States. Colorectal cancer screening is recommended to begin at age 50 years for most men and women at average risk for this disease. Colonoscopy is a gold standard method of screening for colorectal cancer, allowing for the detection and removal of colorectal polyps, some of which can progress into malignancy. The literature has shown that the removal of polyps during a colonoscopy results in decreased incidence and mortality related to colorectal cancer. Indeed, the last decade has shown a decline in colorectal cancer incidence and mortality in adults over age 50, largely due to increased colonoscopy screening. Currently, the risk of a patient developing colorectal cancer and thus time intervals for colonoscopy surveillance post-polypectomy is determined by the number, pathology, and size of the polyps that are observed and removed during the colonoscopy procedure. Current surveillance guidelines indicate the need for a shorter interval before the next colonoscopy for patients who have one or more polyps that are 10mm or larger. In addition, different polypectomy techniques are indicated for the treatment of polyps less than 20mm in size. For example, cold forceps may be appropriate for removal of 1mm to 2mm polyps, cold snare for polyps less than 10mm, and hot-snare resection for polyps 10mm to 19mm. Yet, while the number and pathology of polyps are easily obtained and verified, it is standard practice for the size of a polyp to be assessed through endoscopist optical visualization alone, without use of an objective device or standard by which to measure it. Often, the endoscopist will compare the size of the polyp to the size of the snare loop to estimate and document the size of the polyp(s). However, with the size of a polyp being a major indicator of malignant potential as well as an indicator of appropriate polypectomy technique and surveillance intervals, a device with which to take

Interventions

  • DEVICE Micro-Tech Endoscopic Gauge

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2019-06-24
Est. Completion 2020-06-01
Phase NA

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT03856255

The ClinicalTrials.gov registry entry for NCT03856255 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 36 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 1 intervention - of which Micro-Tech Endoscopic Gauge is the first listed.

NCT03856255 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03856255 about?

NCT03856255 is a clinical study titled "Polyp Measurement Device". Colorectal cancer is the second-leading cause of cancer death in the United States. Colorectal cancer screening is recommended to begin at age 50 years for most men and women at average risk for this disease. Colonoscopy is a gold standard method of screening for colorectal cancer, allowing for the ...

What is the current status of trial NCT03856255?

This trial is currently terminated. It is a NA study. The enrollment target is 36 participants. The study started on 2019-06-24. Estimated completion is 2020-06-01.

What interventions are being tested in trial NCT03856255?

The interventions under investigation include: Micro-Tech Endoscopic Gauge (DEVICE).

Who is sponsoring clinical trial NCT03856255?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.