Polyp Measurement Device



Status:Not yet recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 85
Updated:3/2/2019
Start Date:March 2019
End Date:July 2019
Contact:Christopher Hawryluk
Email:christopher.hawryluk@nyulangone.org
Phone:212-263-9177

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

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.


Inclusion Criteria:

- Individuals age 50-85 years old, who require an outpatient screening or surveillance
colonoscopy

- Ability to give consent

Exclusion Criteria:

- Pregnancy

- Inflammatory bowel disease
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Mark Pochapin, MD
Phone: 212-263-9177
New York University School of Medicine NYU School of Medicine has a proud history that...
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