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Development and Validation of a NIRS-based Sinusitis Screening

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485484
First received: October 28, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

The research at UCI Beckman laser institute and Praxis Biosciences LLC, develope near-infrared (NIR) trans-illumination methods. The optical imaging tool that can determine acute sinusitis and the response to treatment therapy.


Condition Intervention Phase
Sinusitis
 Device: Sinusitis Screening
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Development and Validation of a NIRS-based Sinusitis Screening

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Optical imaging NIR tool to assess of sinusitis [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Assessment of sinusitis and the response to the treatment.


Estimated Enrollment: 105
Study Start Date: September 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sinusitis Screening
Sinusitis Screening
 Device: Sinusitis Screening
Sinusitis Screening

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 NIR light from the illumination wand travelled through the pallet into the sinuses and exited the face. The NIR 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
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
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
Montana Compton
Investigators
Principal Investigator: Albert Cerussi, PhD UCI Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01485484     History of Changes
Other Study ID Numbers: NIH-LAMMP
Study First Received: October 28, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
sinus

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013