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Sponsored by: |
Acclarent |
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Information provided by: | Acclarent |
ClinicalTrials.gov Identifier: | NCT00231062 |
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
Condition | Intervention | Phase |
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Chronic Sinusitis |
Device: Sinuplasty |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) |
Estimated Enrollment: | 50 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | June 2006 |
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.
The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CP-00313 |
Study First Received: | September 30, 2005 |
Last Updated: | December 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00231062 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
sinusitis rhinitis sinus surgery maxillary ethmoid |
sphenoid frontal FESS sinuplasty |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis Sinusitis |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Paranasal Sinus Diseases Sinusitis Nose Diseases |