Development and Validation of a NIRS-based Sinusitis Screening

Overview

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.

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: July 2020

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.

Interventions

• Device: Optic imaging use near-infrared trans-illumination methods
  • Optic imaging use near-infrared trans-illumination methods

Arms, Groups and Cohorts

• Sinus
  • Optic imaging use near-infrared trans-illumination methods

Clinical Trial Outcome Measures

Primary Measures

• Sinus Health
  • Time Frame: up to 4 weeks
  • Assessment of sinusitis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of California, Irvine
• Collaborator
  • Beckman Laser Institute University of California Irvine
• Provider of Information About this Clinical Study
  • Principal Investigator: Beckman Laser Institute and Medical Center, Naveen Bhandarkar, M.D., Assistant Clinical Professor, Department Otolaryngology – University of California, Irvine
• Overall Official(s)
  • Naveen Bhandarkar, MD, Principal Investigator, University of California, Irvine