Clinical Trial: Optical Frequency Domain Imaging for Assessing Colonic Polyps

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Sensitivity and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: September 20, 2011
Date Started: July 2009
Date Completion:
Last Updated: April 14, 2016
Last Verified: April 2016