NCT00544427

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

17.3 years

First QC Date

October 12, 2007

Last Update Submit

October 31, 2022

Conditions

Keywords

Upper Areo-Digestive tract

Outcome Measures

Primary Outcomes (1)

  • Diagnostic tool

    up to 4 weeks

Interventions

Optical coherence tomography imaging

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Male and female age from new born to all age

You may not qualify if:

  • subject who do not sign consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beckman Laser Institute medical Clinic,University of California,Irvine

Irvine, California, 92612, United States

Location

Children Hospital of Orange

Orange, California, 92868, United States

Location

Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine

Orange, California, 92898, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Brian JF Wong, M.D.,Ph.D.

    Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Brian Wong, M.D.,Ph.D Professor Department of Otolaryngology

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

August 1, 2003

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations