NCT01485484

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 28, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2015

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3.9 years

First QC Date

October 28, 2011

Last Update Submit

October 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sinus Health

    Assessment of sinusitis

    up to 4 weeks

Study Arms (1)

Sinus

Optic imaging use near-infrared trans-illumination methods

Device: Optic imaging use near-infrared trans-illumination methods

Interventions

Optic imaging use near-infrared trans-illumination methods

Sinus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be selected from outpatient clinic at Otolaryngology Clinic at the University of California, Irvine Medical Center.

You may qualify if:

  • Male or female 18 years of age and older
  • Subject with normal sinus
  • Subject who has been diagnosed and confirm by their physician

You may not qualify if:

  • Younger than 18 years old
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCI Beckman Laser Medical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Naveen Bhandarkar, MD

    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
Naveen Bhandarkar, M.D., Assistant Clinical Professor, Department Otolaryngology

Study Record Dates

First Submitted

October 28, 2011

First Posted

December 5, 2011

Study Start

July 28, 2011

Primary Completion

July 7, 2015

Study Completion

July 7, 2015

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations