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Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

2014-08-27 03:48:31 | BioPortfolio

Summary

A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Sinusitis

Intervention

Sinuplasty

Status

Completed

Source

Acclarent

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:48:31-0400

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Medical and Biotech [MESH] Definitions

Inflammation of the NASAL MUCOSA in the SPHENOID SINUS. Isolated sphenoid sinusitis is uncommon. It usually occurs in conjunction with other paranasal sinusitis.

Conditions caused by abnormal CILIA movement in the body, usually causing KARTAGENER SYNDROME, chronic respiratory disorders, chronic SINUSITIS, and chronic OTITIS. Abnormal ciliary beating is likely due to defects in any of the 200 plus ciliary proteins, such as missing motor enzyme DYNEIN arms.

Inflammation of the NASAL MUCOSA in the ETHMOID SINUS. It may present itself as an acute (infectious) or chronic (allergic) condition.

A subcategory of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. The disease is characterized by hypersecretion of mucus accompanied by a chronic (more than 3 months in 2 consecutive years) productive cough. Infectious agents are a major cause of chronic bronchitis.

Inflammation of the NASAL MUCOSA in one or more of the PARANASAL SINUSES.

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