Optical Frequency Domain Imaging for Assessing Colonic Polyps

Not Applicable

Completed

• Conditions: Colonic Polyps
• Interventions: Device: MGH Optical Frequency Domain Imaging (OFDI) System

• Registration Number: NCT01439087
• Lead Sponsor: Massachusetts General Hospital

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 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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2010-08
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Results First Submitted: 2019-08-14
• Results First Submitted QC: 2019-12-09
• Results First Posted: 2019-12-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI imaging	MGH Optical Frequency Domain Imaging (OFDI) System	OFDI imaging

Primary Outcome Measures

Name	Time	Method
Feasibility and Sensitivity of OFDI Imaging in the Colon	During the OFDI imaging session which should take an average of 5 mintues	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States