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Development and Validation of a NIRS-based Sinusitis Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01485484
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : April 2, 2021
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Tracking Information
First Submitted Date October 28, 2011
First Posted Date December 5, 2011
Last Update Posted Date April 2, 2021
Actual Study Start Date July 28, 2011
Actual Primary Completion Date July 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2014)
Sinus Health [ Time Frame: up to 4 weeks ]
Assessment of sinusitis
Original Primary Outcome Measures
 (submitted: December 1, 2011)
Optical imaging NIR tool to assess of sinusitis [ Time Frame: 30 minutes ]
Assessment of sinusitis and the response to the treatment.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development and Validation of a NIRS-based Sinusitis Screening
Official Title Development and Validation of a NIRS-based Sinusitis Screening
Brief Summary 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Sinusitis
Intervention Device: Optic imaging use near-infrared trans-illumination methods
Optic imaging use near-infrared trans-illumination methods
Study Groups/Cohorts Sinus
Optic imaging use near-infrared trans-illumination methods
Intervention: Device: Optic imaging use near-infrared trans-illumination methods
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 1, 2021)
161
Original Estimated Enrollment
 (submitted: December 1, 2011)
105
Actual Study Completion Date July 7, 2015
Actual Primary Completion Date July 7, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01485484
Other Study ID Numbers NIH/LAMMP-2011-8295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Beckman Laser Institute and Medical Center, University of California, Irvine
Study Sponsor University of California, Irvine
Collaborators Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Naveen Bhandarkar, MD University of California, Irvine
PRS Account University of California, Irvine
Verification Date March 2021