Near Infrared Transillumination of the Paranasal Sinuses
| Tracking Information | |||||
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| First Received Date ICMJE | October 12, 2007 | ||||
| Last Updated Date | October 28, 2011 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00543998 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | primary care clinic, |
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| Condition ICMJE | Sinusitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 33 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | June 2005 (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 Number ICMJE | NCT00543998 | ||||
| Other Study ID Numbers ICMJE | LAMMP. | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Montana Compton, University of California, Irvine | ||||
| Study Sponsor ICMJE | Montana Compton | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | October 2011 | ||||
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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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