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The Investigation of a Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device for Oral Tissue Characterization

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Department of Defense
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00764569
First received: October 1, 2008
Last updated: November 29, 2011
Last verified: October 2011
History of Changes
  Purpose

The overall objective of this work is to identify changes in the optical properties of oral tissues to develop a non-invasive tool for the detection, diagnosis and screening of oral pathology so that treatment can be provided at the earliest possible time.


Condition Intervention
Other Lesions of Oral Mucosa
 Device: Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device

Study Type: Observational
Official Title: a Non-invasive Device for the Detection, Diagnosis and Screening of Oral Pathology

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • the instrument could use in the future to detect pre-cancer and cancer. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
oral imaging Device: Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device
Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device

Detailed Description:

Specifically, we will be obtaining optical spectroscopic data using a fiber optic contact probe that exploits elastic-scattering spectroscopy (ESS) and fluorescence spectroscopy. Both of these technique have independently shown to provide signatures for the onset of cancer, with varied success. The purpose of this effort is to combine the two techniques and develop and understanding of the signatures obtained in both normal and abnormal oral tissue with simultaneous collection of these optical signatures.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • adult over 18 years of age

Exclusion Criteria:

  • younger than 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764569

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
UCI student health center
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Department of Defense
Investigators
Principal Investigator: Petra Wilder-Smith, DDS, PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00764569     History of Changes
Other Study ID Numbers: DOD W81XWH-08-1-008
Study First Received: October 1, 2008
Last Updated: November 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
oral tissue

ClinicalTrials.gov processed this record on June 18, 2013