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NCT01979458 Clinical Trial

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

Colonic Polyps Clinical Trial

Official title:
Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01979458
Other study ID # 2013P001115
Secondary ID
Status Completed
Phase N/A
First received November 4, 2013
Last updated March 22, 2017
Start date November 2013
Est. completion date July 2014

Study information
Verified date September 2014
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• PSE

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Image Contrast Comparison of image contrast obtained using standard colonoscopy and PSE. Immediate
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