Development and Validation of a NIRS-based Sinusitis Screening

Completed

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

• Registration Number: NCT01485484
• Lead Sponsor: University of California, Irvine

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 Timeline

• Study Start: 2011-07-28
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2015-07-07
• Study Completion: 2015-07-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sinus	Optic imaging use near-infrared trans-illumination methods	Optic imaging use near-infrared trans-illumination methods

Primary Outcome Measures

Name	Time	Method
Sinus Health	up to 4 weeks	Assessment of sinusitis

Trial Locations

Locations (1)

UCI Beckman Laser Medical Clinic; 🇺🇸 Irvine, California, United States