Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
March 22, 2017 updated by: Norman Nishioka, MD, Massachusetts General Hospital
Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique.
Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing a routine colonoscopy screening
- Patients must be over the age of 18
- Patients must be able to give informed consent
Exclusion Criteria:
- Patients with bleeding/hemostasis disorders
- Patients that are pregnant
- Patients taking any anti-coagulants that would preclude them from undergoing a standard of care colonoscopy, such as Coumadin and Plavix, at the time of the study
- Patients with known colitis or active bleeding will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PSE
Patients whose distal colon is imaged using the PSE device.
This is a pilot trial of 30 patients.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image Contrast
Time Frame: Immediate
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Comparison of image contrast obtained using standard colonoscopy and PSE.
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Immediate
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
November 4, 2013
First Submitted That Met QC Criteria
November 7, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P001115
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.