NCT01439087

Optical Frequency Domain Imaging for Assessing Colonic Polyps

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	MGH Optical Frequency Domain Imaging (OFDI) System	Imaging of Colonic Polyps with OFDI system

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-10-01
• Completion: 2010-08-01
• First posted: 2011-09-22
• Last updated: 2023-07-27
• Results posted: 2019-12-30

Locations

1 site across 1 country: United States