Development and Validation of a NIRS-based Sinusitis Screening

• ClinicalTrials.gov Identifier: NCT01485484
• Recruitment Status: Completed
• First Posted: December 5, 2011
• Last Update Posted: April 2, 2021
• Sponsor: University of California, Irvine
• 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.

• 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

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

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