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

Chronic Sinusitis Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

• NCT number: NCT00231062
• Study type: Interventional
• Source: Acclarent
• Status: Completed
• Phase: Phase 3
• Start date: April 2005
• Completion date: June 2006