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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: October 31, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Sinusitis
Device: Optic imaging use near-infrared trans-illumination methods
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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:
  • Sinus Health [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
    Assessment of sinusitis


Estimated Enrollment: 170
Study Start Date: September 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sinus
Optic imaging use near-infrared trans-illumination methods
Device: Optic imaging use near-infrared trans-illumination methods
Optic imaging use near-infrared trans-illumination methods

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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

Locations
United States, California
UCI Beckman Laser Medical Clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Naveen Bhandarkar, MD University of California, Irvine
  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-2011-8295
Study First Received: October 28, 2011
Last Updated: October 31, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014