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

NCT ID: NCT00544427

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Disorder of Upper Digestive Tract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Optical coherence tomography

Optical coherence tomography imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female age from new born to all age

Exclusion Criteria

* subject who do not sign consent form
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Orange County

OTHER

Sponsor Role collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Brian Wong, M.D.,Ph.D Professor Department of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian JF Wong, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine

Locations

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Beckman Laser Institute medical Clinic,University of California,Irvine

Irvine, California, United States

Site Status

Children Hospital of Orange

Orange, California, United States

Site Status

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

Orange, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26214043 (View on PubMed)

Other Identifiers

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20033025

Identifier Type: -

Identifier Source: org_study_id

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