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Terminated Not applicable Interventional Accepts healthy volunteers Results available

Polyp Measurement Device

ClinicalTrials.gov ID: NCT03856255

Public ClinicalTrials.gov record NCT03856255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 18, 2026, 5:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Pilot, Single-centered, Single-arm, Feasibility Study Evaluating a Polyp Measurement Device in Patients Undergoing Screening or Surveillance Colonoscopy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 and document accurate and objective measurements of polyps during colonoscopy holds the potential for health benefits. In addition to having a potential clinical benefit for each patient in terms of polypectomy and surveillance intervals, as an objective indicator of polyp size, this technique also holds promise for use in future studies that evaluate polyp size as an indicator of potential malignancy (or future malignancy) and for use by national clinical guidelines committees who may utilize these objective data to update future screening and surveillance recommendations.

Study identification

NCT ID
NCT03856255
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
NYU Langone Health
Other
Enrollment
36 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
50 Years to 85 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 23, 2019
Primary completion
May 31, 2020
Completion
May 31, 2020
Last update posted
Jun 13, 2021

2019 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
New York University School of Medicine New York New York 10016

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03856255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 13, 2021 · Synced Sep 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03856255 live on ClinicalTrials.gov.

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