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NCT01623050 Clinical Trial

Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

Sinusitis Clinical Trial

Official title:
SinuSys Patency of Maxillary Sinus Ostia Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01623050
Other study ID # SNS-005
Secondary ID
Status Completed
Phase Phase 1
First received June 13, 2012
Last updated October 30, 2014
Start date April 2012
Est. completion date September 2014

Study information
Verified date October 2014
Source SinuSys Corporation
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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

Description:

A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date September 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• SinuSys Dilation System
Sinuplasty

Locations
Country Name City State
Canada St. Paul's Hospital, ENT Department Vancouver British Columbia
United Kingdom Charing Cross Hospital London
United States St. Elizabeth Medical Center Boston Massachusetts
United States Palo Alto Medical Foundation Palo Alto California
United States Valley ENT Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
SinuSys Corporation

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patency of Treated Area Immediately post procedure No
Secondary Patency of Treated Area Maxillary Sinus Ostia Patency of 33 patients analyzed. 3 months No
Secondary Number of Participants With Device-related Adverse Events as a Measure of Safety 3 months Yes
Secondary Patency of Treated Area Maxillary Sinus Ostia Patency of 29 patients analyzed. 6 months No
Secondary Patency of Treated Area Maxillary Sinus Ostia of 27 patients analyzed. 12 months No
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