We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979458
First Posted: November 8, 2013
Last Update Posted: March 24, 2017
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):
Norman Nishioka, MD, Massachusetts General Hospital
  Purpose
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 Intervention
Colonic Polyps Device: PSE

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Norman Nishioka, MD, Massachusetts General Hospital:

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


Estimated Enrollment: 30
Study Start Date: November 2013
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT01979458


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: Norman Nishioka, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01979458     History of Changes
Other Study ID Numbers: 2013P001115
First Submitted: November 4, 2013
First Posted: November 8, 2013
Last Update Posted: March 24, 2017
Last Verified: September 2014

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:
Colonoscopy

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