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Optical Frequency Domain Imaging for Assessing Colonic Polyps

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439087
First Posted: September 22, 2011
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
  Purpose
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.

Condition Intervention Phase
Colonic Polyps Device: MGH Optical Frequency Domain Imaging (OFDI) System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps

Resource links provided by NLM:


Further study details as provided by Guillermo Tearney, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]
    OFDI Images will be analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps


Enrollment: 15
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFDI imaging
OFDI imaging
Device: MGH Optical Frequency Domain Imaging (OFDI) System
Imaging of Colonic Polyps with OFDI system

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439087


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
  More Information

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01439087     History of Changes
Other Study ID Numbers: 2009-P-000946
First Submitted: September 20, 2011
First Posted: September 22, 2011
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Colonic Polyps
OCT
Imaging
Colon
Polyp

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps