NCT00543998

Brief Summary

This research project designed to diagnose sinusitis using a simple and low-cost optical tool. Healthy sinuses are typically filled with air, and show up as bright spots on the camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments on the sinuses have been successful.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2003

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

October 12, 2007

Last Update Submit

October 28, 2022

Conditions

Sinusitis

Keywords

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Healthy Sinus

    12 weeks

Study Arms (1)

Optical Measurement transillumination

Optical Measurement of sinus

Device: Optical Measurement transillumination

Interventions

Optical Measurement transilluminationDEVICE

Optical Measurement of sinus

Optical Measurement transillumination

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic,

You may qualify if:

  • male and female age of 15 years or older.
  • Has diagnose of sinusitis, nasal allergies,nasal breathing problem, and tumors.

You may not qualify if:

  • Age less than 15 year sold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute Medical Cinic, University of California,Irvine

Irvine, California, 92612, United States

Location

Otolaryngology Medical Clinic, University of California, Irvine

Irvine, California, 92868, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Brian JF Wong, M.D.,Ph.D

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.J Wong, M.D.,Ph.D., Professor Department of Otolaryngology

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

May 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(2)