Development and Validation of a NIRS-based Sinusitis Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01485484
First received: October 28, 2011
Last updated: May 19, 2014
Last verified: May 2014
  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: Optical imaging NIR
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:


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
Optical imaging NIR
Sinus assessment
Device: Optical imaging NIR
Sinus assessment
Other Name: Optical imaging NIR

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485484

Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
United States, California
UCI Beckman Laser Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Principal Investigator: Albert Cerussi, PhD         
Sub-Investigator: Naveen Bhandarkar, MD         
Sub-Investigator: Montana Compton, RN         
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: May 19, 2014
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 August 20, 2014