Overview

This trial is active, not recruiting.

Condition sinusitis
Treatment sinusys dilation system
Phase phase 1
Sponsor SinuSys Corporation
Start date April 2012
End date June 2013
Trial size 40 participants
Trial identifier NCT01623050, SNS-005

Summary

The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sinusys dilation system
Sinuplasty

Primary Outcomes

Measure
Patency of treated area
time frame: Immediately post procedure

Secondary Outcomes

Measure
Patency of treated area
time frame: 3 months, 6 months and 12 months
Number of participants with Adverse Events as a measure of Safety
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: -Diagnosis of chronic maxillary sinusitis Exclusion Criteria: - Previous antrostomy - Sinonasal tumours - Cystic fibrosis - History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus - Pregnant or breastfeeding females - Currently participating in another drug or device study

Additional Information

Official title SinuSys Patency of Maxillary Sinus Ostia Study
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by SinuSys Corporation.