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

October 31, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine

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.

Study Overview

Status

Withdrawn

Conditions

Disorder of Upper Digestive Tract

Intervention / Treatment

Device: Optical coherence tomography

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Irvine, California, United States, 92612
    - Beckman Laser Institute medical Clinic,University of California,Irvine
  - Orange, California, United States, 92868
    - Children Hospital of Orange
  - Orange, California, United States, 92898
    - Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

Male and female age from new born to all age

Exclusion Criteria:

subject who do not sign consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic tool Time Frame: up to 4 weeks	up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Children's Hospital of Orange County

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)