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Development and Validation of a NIRS-based Sinusitis Screening

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485484
First Posted: December 5, 2011
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.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
The research at University of California Irvine, Beckman laser institute and Praxis Biosciences Incorporation, develope near-infrared trans-illumination methods. The optical imaging tool that can determine acute sinusitis and the response to treatment therapy.

Condition Intervention
Sinusitis Device: Optic imaging use near-infrared trans-illumination methods

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development and Validation of a NIRS-based Sinusitis Screening

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Sinus Health [ Time Frame: up to 4 weeks ]
    Assessment of sinusitis


Estimated Enrollment: 170
Study Start Date: September 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sinus
Optic imaging use near-infrared trans-illumination methods
Device: Optic imaging use near-infrared trans-illumination methods
Optic imaging use near-infrared trans-illumination methods

Detailed Description:
In the United States, approximately one in seven people develop sinusitis each year, and 20 million cases of acute bacterial sinusitis become chronic to require medical treatment. The optic light from the illumination wand travelled through the pallet into the sinuses and exited the face. The optic device can determine air-filled and fluid/tissue-filled spaces in the sinus cavity during clinical exam.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from outpatient clinic at Otolaryngology Clinic at the University of California, Irvine Medical Center.
Criteria

Inclusion Criteria:

  • Male or female 18 years of age and older
  • Subject with normal sinus
  • Subject who has been diagnosed and confirm by their physician

Exclusion Criteria:

  • Younger than 18 years old
  • Pregnant women
  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): NCT01485484


Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
United States, California
UCI Beckman Laser Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Principal Investigator: Naveen Bhandarkar, MD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Naveen Bhandarkar, MD University of California, Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Naveen Bhandarkar, M.D., Assistant Clinical Professor, Department Otolaryngology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01485484     History of Changes
Other Study ID Numbers: NIH/LAMMP-2011-8295
First Submitted: October 28, 2011
First Posted: December 5, 2011
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases