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Development and Validation of a NIRS-based Sinusitis Screening

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ClinicalTrials.gov Identifier: NCT01485484
Recruitment Status : Suspended (Awaiting IRB renewal)
First Posted : December 5, 2011
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Sinusitis Device: 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development and Validation of a NIRS-based Sinusitis Screening
Study Start Date : September 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
United States, California
UCI Beckman Laser Medical Clinic
Irvine, California, United States, 92612
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 5, 2011    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

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