Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 1:06 PM
Study NCT ID:
NCT00764569
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2008-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Investigation of a Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device for Oral Tissue Characterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Tool', 'timeFrame': '4 weeks', 'description': 'Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oral tissue'], 'conditions': ['Other Lesions of Oral Mucosa']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Specifically, we will be obtaining optical spectroscopic data using a fiber optic contact probe that exploits elastic-scattering spectroscopy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult over 18 years of age\n\nExclusion Criteria:\n\n* younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT00764569', 'briefTitle': 'The Investigation of a Fluorescence/Elastic Scattering Spectroscopy (F-ESS) Device for Oral Tissue Characterization', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'a Non-invasive Device for the Detection, Diagnosis and Screening of Oral Pathology', 'orgStudyIdInfo': {'id': '20086355'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral Tissue measurement', 'description': 'Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement', 'interventionNames': ['Device: Fluorescence/Elastic Scattering Spectroscopy']}], 'interventions': [{'name': 'Fluorescence/Elastic Scattering Spectroscopy', 'type': 'DEVICE', 'description': 'Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement', 'armGroupLabels': ['Oral Tissue measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Laser Institute Medical clinic', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCI student health center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Petra Wilder-Smith, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute University of California Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beckman Laser Institute University of California Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}