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Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

NCT01854619 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-05-17

No results posted yet for this study

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.

Conditions

  • Chronic Sinusitis

Interventions

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.

Sponsors & Collaborators

  • Ondine Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Desrosiers, MD · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854619 on ClinicalTrials.gov