Optical Frequency Domain Imaging for Assessing Colonic Polyps

Colonic Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439087
• Other study ID #: 2009-P000946
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Intervention

Device:
• MGH Optical Frequency Domain Imaging (OFDI) System
Imaging of Colonic Polyps with OFDI system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Sensitivity of OFDI Imaging in the Colon	OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.	During the OFDI imaging session which should take an average of 5 mintues