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

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544427
First Posted: October 16, 2007
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Children’s Hospital of Orange County
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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 Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Diagnostic tool [ Time Frame: up to 4 weeks ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Male and female age from new born to all age

Exclusion Criteria:

  • subject who do not sign consent form
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544427


Contacts
Contact: Brian JF Wong, M.D.,Ph.D 714-456-5753 bjwong@uci.edu
Contact: Giriraj Sharma, M.D 714-456-5753 sharmagk@uci.edu

Locations
United States, California
Beckman Laser Institute medical Clinic,University of California,Irvine Recruiting
Irvine, California, United States, 92612
Contact: Giriraj Sharma, M.D    714-456-5753    sharmagk@uci.edu   
Principal Investigator: Brian JF Wong, M.D.,Ph.D         
Sub-Investigator: Girirj K Sharma, MD         
Children Hospital of Orange Recruiting
Orange, California, United States, 92868
Contact: Giriraj Sharma, MD    714-456-5753    sharmagk@uci.edu   
Sub-Investigator: Gurpeet Ahuja, MD         
Sub-Investigator: Girirj K Sharma, MD         
Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine Recruiting
Orange, California, United States, 92898
Contact: Brian JF Wong, M.D.,Ph.D    714-456-5753    bjwong@uci.edu   
Contact: Girirj Sharma, M.D    714-456-5753    sharmagk@uci.edu   
Principal Investigator: Brian Wong, M.D         
Sub-Investigator: Gurpeet Ahuja, MD         
Sub-Investigator: Girirj K Sharma, MD         
Sponsors and Collaborators
University of California, Irvine
Children’s Hospital of Orange County
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Brian JF Wong, M.D.,Ph.D. Beckman Laser Institute Medical Clinic,University ofCalifornia,Irvine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beckman Laser Institute and Medical Center, Brian Wong, M.D.,Ph.D Professor Department of Otolaryngology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00544427     History of Changes
Other Study ID Numbers: NIH/LAMMP-2003-3025
First Submitted: October 12, 2007
First Posted: October 16, 2007
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Upper Areo-Digestive tract

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases