Optical Frequency Domain Imaging for Assessing Colonic Polyps



Status:Completed
Conditions:Colorectal Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:July 2009
End Date:August 2010

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Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps

The goal of this research is to conduct a pilot clinical study to image colonic polyps with
the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to
identify the extent of invasion (if present), differentiate between hyperplastic polyps and
adenomas, and identify serrated polyps.

The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp
is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI
catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to
the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and
the base/stalk if pedunculated. The investigators anticipate that on average the
investigators will utilize 4 helical scans per polyp. Each of the scans will take less than
30 seconds.

Inclusion Criteria:

- Patients undergoing a screening colonoscopy

- Patients must be over the age of 18

- Patient must be able to give informed consent

Exclusion Criteria:

- Patients with hemostasis disorders

- Patients taking any anti-coagulants such as Coumadin or Plavix,
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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