- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01485484
Development and Validation of a NIRS-based Sinusitis Screening
October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
161
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Irvine, California, United States, 92612
- UCI Beckman Laser Medical Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sinus
Optic imaging use near-infrared trans-illumination methods
|
Optic imaging use near-infrared trans-illumination methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sinus Health
Time Frame: up to 4 weeks
|
Assessment of sinusitis
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Naveen Bhandarkar, MD, University of California, Irvine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2011
Primary Completion (Actual)
July 7, 2015
Study Completion (Actual)
July 7, 2015
Study Registration Dates
First Submitted
October 28, 2011
First Submitted That Met QC Criteria
December 1, 2011
First Posted (Estimate)
December 5, 2011
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20118295
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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