Status:
UNKNOWN
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
Lead Sponsor:
Ondine Biomedical Inc.
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the use of light and a topically applied photosensitizer can relieve symptoms and clinically improve patients with chronic rhinosinusitis.
Detailed Description
This clinical trial will be a prospective, randomized, single-center study utilizing two treatment assignments and a control group. The study is expected to enroll a total of 48 subjects. The intent o...
Eligibility Criteria
Inclusion
- history of chronic rhinosinusitis with and without nasal polyposis
- no antibiotics within 4 weeks
- no oral steroid use within 4 weeks
- no topical steroid use within 2 weeks
- endoscopic sinus surgery greater than 6 months previously
Exclusion
- acute respiratory infection within last 2 weeks
- septal deviation restricting sinus access
- known allergy to methylene blue
- pregnant or breast feeding
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01854619
Start Date
May 1 2013
End Date
March 1 2014
Last Update
May 17 2013
Active Locations (1)
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1
Centre hospitalier de l'UdeM (CHUM)
Montreal, Quebec, Canada, H2W 1T8