Optical Frequency Domain Imaging for Assessing Colonic Polyps
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedResults Posted
Study results publicly available
December 30, 2019
CompletedJuly 27, 2023
July 1, 2023
3 months
September 20, 2011
August 14, 2019
July 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
OFDI imaging
EXPERIMENTALOFDI imaging
Interventions
Imaging of Colonic Polyps with OFDI system
Eligibility Criteria
You may qualify if:
- Patients undergoing a screening colonoscopy
- Patients must be over the age of 18
- Patient must be able to give informed consent
You may not qualify if:
- Patients with hemostasis disorders
- Patients taking any anti-coagulants such as Coumadin or Plavix,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Tearney, MD, PhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Tearney, MD PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pathology
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 22, 2011
Study Start
July 1, 2009
Primary Completion
October 1, 2009
Study Completion
August 1, 2010
Last Updated
July 27, 2023
Results First Posted
December 30, 2019
Record last verified: 2023-07