The Investigation of a Fluorescence/Elastic Scattering Sp... | NCT00764569

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

NCT00764569

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

77Actual

Phase

Not provided

Conditions

Other Lesions of Oral Mucosa

Interventions

Fluorescence/Elastic Scattering Spectroscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Oct 1, 2008

First Submission Date that Met QC Criteria

Oct 1, 2008

First Posted Date

Oct 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Tissue measurement		Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement	Device: Fluorescence/Elastic Scattering Spectroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorescence/Elastic Scattering Spectroscopy	Device	Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement	Oral Tissue measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic Tool	Fluorescence/Elastic Scattering Spectroscopy Oral tissue measurement	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult over 18 years of age

Exclusion Criteria:

younger than 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petra Wilder-Smith, DDS, PhD	Beckman Laser Institute University of California Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute Medical clinic		Irvine	California	92612	United States
UCI student health center