Clinical Trial: Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Photodisinfection for the Treatment of Chronic Rhinosinusitis
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 Summary: 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 of the study is to evaluate a single versus double treatment of photodisinfection in men and women suffering from chronic persistent rhinosinusitis with and without nasal polyposis. Each photodisinfection treatment group will be compared to a control group receiving saline irrigation.
Sponsor: Ondine Biomedical Inc.
Current Primary Outcome: SNOT-22 [ Time Frame: 6 months ]
Original Primary Outcome: SNOT-22 [ Time Frame: 6 months ]
Current Secondary Outcome: Microbiome evaluation [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Ondine Biomedical Inc.
Dates:
Date Received: May 13, 2013
Date Started: May 2013
Date Completion: March 2014
Last Updated: May 15, 2013
Last Verified: May 2013