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

This study is currently recruiting participants.
Verified November 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Norman Nishioka, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01979458
First received: November 4, 2013
Last updated: November 15, 2013
Last verified: November 2013
  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: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Image Contrast [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    Comparison of image contrast obtained using standard colonoscopy and PSE.


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979458

Contacts
Contact: Norman S Nishioka, MD 6177264422 nnishioka@partners.org
Contact: William Puricelli, RN 6177247461 wpuricelli@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Norman S Nishioka, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Norman Nishioka, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01979458     History of Changes
Other Study ID Numbers: 2013P001115
Study First Received: November 4, 2013
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Colonoscopy

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

ClinicalTrials.gov processed this record on April 16, 2014