NCT01854619

Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Photodisinfection for the Treatment of Chronic Rhinosinusitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ondine Biomedical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	Photodisinfection (antimicrobial photodynamic therapy, aPDT)	A 0.03% solution of methylene blue is irrigated into the involved paranasal sinus followed by placement of a saline filled balloon with a center light diffusing fiber optic. This is illuminated at 150 mW/cm2 power density for 8 minutes. This is repeated for each involved sinus.
DEVICE	Saline irrigation	The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-05-15
• Last updated: 2013-05-17

Locations

1 site across 1 country: Canada