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| Tracking Information | |||||
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| First Received Date ICMJE | October 12, 2007 | ||||
| Last Updated Date | August 31, 2009 | ||||
| Start Date ICMJE | May 2003 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00543998 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Near Infrared Transillumination of the Paranasal Sinuses | ||||
| Official Title ICMJE | Near Infrared Transillumination of the Paranasal Sinuses | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Sinusitis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2012 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00543998 | ||||
| Responsible Party | Brian J Wong, M.D.,Ph.D, Beckman Laser Institute | ||||
| Study ID Numbers ICMJE | LAMMP. | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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