Development and Validation of a NIRS-based Sinusitis Screening
This study is enrolling participants by invitation only.
Sponsor:
University of California, Irvine
Collaborators:
Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485484
First received: October 28, 2011
Last updated: January 14, 2015
Last verified: January 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sinusitis |
Device: Optic imaging use near-infrared trans-illumination methods |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Development and Validation of a NIRS-based Sinusitis Screening |
Resource links provided by NLM:
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- Sinus Health [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]Assessment of sinusitis
| Estimated Enrollment: | 170 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Sinus
Optic imaging use near-infrared trans-illumination methods
|
Device: Optic imaging use near-infrared trans-illumination methods
Optic imaging use near-infrared trans-illumination methods
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485484
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485484
Locations
| United States, California | |
| UCI Beckman Laser Medical Clinic | |
| Irvine, California, United States, 92612 | |
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Investigators
| Principal Investigator: | Naveen Bhandarkar, MD | University of California, Irvine |
More Information
No publications provided
| Responsible Party: | Beckman Laser Institute and Medical Center, Principal Investigator, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT01485484 History of Changes |
| Other Study ID Numbers: | NIH/LAMMP-2011-8295 |
| Study First Received: | October 28, 2011 |
| Last Updated: | January 14, 2015 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Sinusitis Nose Diseases Otorhinolaryngologic Diseases |
Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on March 03, 2015