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NCT01485484 Clinical Trial

Development and Validation of a NIRS-based Sinusitis Screening

Sinusitis Clinical Trial

Official title:
Development and Validation of a NIRS-based Sinusitis Screening

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01485484
Other study ID # 20118295
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 28, 2011
Est. completion date July 7, 2015

Study information
Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date July 7, 2015
Est. primary completion date July 7, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Optic imaging use near-infrared trans-illumination methods
Optic imaging use near-infrared trans-illumination methods

Locations
Country Name City State
United States UCI Beckman Laser Medical Clinic Irvine California

Sponsors (2)
Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sinus Health Assessment of sinusitis up to 4 weeks
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