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| Sponsor: | University of California, Irvine |
|---|---|
| Collaborators: |
Beckman Laser Institute University of California Irvine Otolaryngology Medical Clinic,University of California, Irvine |
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00543998 |
Purpose
This research project designed to diagnose sinusitis using a simple and low-cost optical tool. Healthy sinuses are typically filled with air, and show up as bright spots on the camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments on the sinuses have been successful.
Sinusitis is among the most common conditions leading to consultation with primary care physicians. Sinusitis is an infection of the air-spaced in the face that surround the nasal cavity. It usually complicates a cold or upper respiratory infection.The economic impact on of this disorder is immense with approximately 31 million Americans seeking treatment each year. Presently, X-rays and CT scans are used to diagnose sinusitis. In contrast, the optical tool is low cost, safe, and can be performed in the doctor's office. The optical tool is intended to provide an alternative to X-ray and CT scans.
| Condition |
|---|
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Sinusitis |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Near Infrared Transillumination of the Paranasal Sinuses |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
This device consists of a specialized flashlight that uses mostly non-visible light, and a small camera to record the light. The tool is the size and shape of spoon. The technique of shining light into the mouth, face, and sinuses is known as "transillumination" and has been used for nearly a century to aid in the diagnosis of sinusitis. The tool described in this study is a custom made device that uses light that is invisible to the eye.
Eligibility| Ages Eligible for Study: | 15 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
primary care clinic,
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Otolaryngology Medical Clinic, University of California, Irvine | |
| Irvine, California, United States, 92868 | |
| Beckman Laser Institute Medical Cinic, University of California,Irvine | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | Brian JF Wong, M.D.,Ph.D | Beckman Laser Institute University of California Irvine |
More Information
| Responsible Party: | Beckman Laser Institute ( Brian J Wong, M.D.,Ph.D ) |
| Study ID Numbers: | LAMMP. |
| Study First Received: | October 12, 2007 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00543998 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Sinusitis |
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Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Paranasal Sinus Diseases Sinusitis Nose Diseases |
