Clinical trial NCT00544427: Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract
Official title: Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorder of Upper Digestive Tract
Keywords: Upper Areo-Digestive tract
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Orange County
name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: Inclusion Criteria:

* Male and female age from new born to all age

Exclusion Criteria:

* subject who do not sign consent form

Primary outcomes:
measure: Diagnostic tool
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute medical Clinic,University of California,Irvine
state: California
city: Orange
country: United States
facility: Children Hospital of Orange
state: California
city: Orange
country: United States
facility: Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine
name: Brian JF Wong, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.