Back to resultsPhotometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Primary Purpose
Colonic Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PSE
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Polyps focused on measuring Colonoscopy
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSE
Arm Description
Patients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients.
Outcomes
Primary Outcome Measures
Image Contrast
Comparison of image contrast obtained using standard colonoscopy and PSE.
Secondary Outcome Measures
Full Information
NCT ID
NCT01979458
First Posted
November 4, 2013
Last Updated
March 22, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01979458
Brief Title
Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Official Title
Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSE
Arm Type
Experimental
Arm Description
Patients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients.
Intervention Type
Device
Intervention Name(s)
PSE
Other Intervention Name(s)
photometric stereo endoscopy
Primary Outcome Measure Information:
Title
Image Contrast
Description
Comparison of image contrast obtained using standard colonoscopy and PSE.
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
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