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Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon

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. Identifier: NCT01979458
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : March 24, 2017
Information provided by (Responsible Party):
Norman Nishioka, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Device: PSE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PSE
Patients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients.
Device: PSE
Other Name: photometric stereo endoscopy

Primary Outcome Measures :
  1. Image Contrast [ Time Frame: Immediate ]
    Comparison of image contrast obtained using standard colonoscopy and PSE.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01979458

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Norman Nishioka, MD, Physician, Massachusetts General Hospital Identifier: NCT01979458     History of Changes
Other Study ID Numbers: 2013P001115
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: September 2014

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norman Nishioka, MD, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Pathological Conditions, Anatomical