Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Otolaryngology-Head & Neck Surgery, UCIMC
Children’s Hospital of Orange County
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine Identifier:
First received: October 12, 2007
Last updated: January 14, 2015
Last verified: January 2015

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.

Condition Intervention
Disorder of Upper Digestive Tract
Device: Optical coherence tomography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Diagnostic tool [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: August 2003
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Optical coherence tomography
    Optical coherence tomography imaging
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.


Inclusion Criteria:

  • Male and female age from new born to all age

Exclusion Criteria:

  • subject who do not sign consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00544427

United States, California
Beckman Laser Institute medical Clinic,University of California,Irvine
Irvine, California, United States, 92612
Children Hospital of Orange
Orange, California, United States, 92868
Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine
Orange, California, United States, 92898
Sponsors and Collaborators
University of California, Irvine
Otolaryngology-Head & Neck Surgery, UCIMC
Children’s Hospital of Orange County
Principal Investigator: Brian JF Wong, M.D.,Ph.D. Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Principal Investigator, University of California, Irvine Identifier: NCT00544427     History of Changes
Other Study ID Numbers: NIH/LAMMP-2003-3025
Study First Received: October 12, 2007
Last Updated: January 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Upper Areo-Digestive tract processed this record on February 27, 2015