Near Infrared Optical Coherence Tomography of the Upper A... | NCT00544427

Studies
Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

NCT00544427

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Nov 2, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Disorder of Upper Digestive Tract

Interventions

Optical coherence tomography

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Doesn't meet NIH clinical trial definition.

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Oct 12, 2007

First Submission Date that Met QC Criteria

Oct 12, 2007

First Posted Date

Oct 16, 2007Estimated

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 31, 2022

Last Update Posted Date

Nov 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Brian Wong, M.D.,Ph.D Professor Department of Otolaryngology, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Children's Hospital of Orange County	OTHER
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 Optical Coherence Tomography is a minimally-invasive diagnostic tool in both the office and operating room settings can identify sources of airway obstruction and effective surgical interventions. The researcher can use Optical Coherence Tomography to image tissues of the aero-digestive tract during surgical endoscopy in to the nose, oral cavity, larynx and ear in an outpatient clinic setting.

Detailed Description

The Optical Coherence Tomography imaging system has low power non-laser broad band infrared light shine onto laryngeal, esophageal, tracheal, oral, nasal and ear tissue and does not involve input of significant amounts of energy and no temperature rise occurs.

The gradual development and acceptance of Optical Coherence Tomography as an imaging modality serves as an alternative to invasive tissue biopsy as a diagnostic measure. Imaging diagnosis, can implement and more convenient than tissue biopsy and can reduce procedural complications.

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

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical coherence tomography	Device	Optical coherence tomography imaging

Measure	Description	Time Frame
Diagnostic tool		up to 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female age from new born to all age

Exclusion Criteria:

subject who do not sign consent form

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Study population will be sekected from University of California Iriven Medical Cente department of Otolarygology/Head and neck surgery, Chao Digestive Diseases Center, Neonatal Intensive Care Unit and Beckman laser Institute and Children Hospital of Orange Pediatric Department.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian JF Wong, M.D.,Ph.D.	Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute medical Clinic,University of California,Irvine		Irvine	California	92612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26214043	Derived	Sharma GK, Ahuja GS, Wiedmann M, Osann KE, Su E, Heidari AE, Jing JC, Qu Y, Lazarow F, Wang A, Chou L, Uy CC, Dhar V, Cleary JP, Pham N, Huoh K, Chen Z, Wong BJ. Long-Range Optical Coherence Tomography of the Neonatal Upper Airway for Early Diagnosis of Intubation-related Subglottic Injury. Am J Respir Crit Care Med. 2015 Dec 15;192(12):1504-13. doi: 10.1164/rccm.201501-0053OC.

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures