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

Phase 1

Completed

• Conditions: Sinusitis
• Interventions: Device: SinuSys Dilation System

• Registration Number: NCT01623050
• Lead Sponsor: SinuSys Corporation

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Primary Completion: 2013-06
• Study Completion: 2014-09
• Results First Submitted: 2014-09-26
• Results First Submitted QC: 2014-09-26
• Status Verified: 2014-10
• Results First Posted: 2014-10-01
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SinuSys Dilation System	SinuSys Dilation System	Maxillary Sinus Dilation

Primary Outcome Measures

Name	Time	Method
Patency of Treated Area	Immediately post procedure

Secondary Outcome Measures

Name	Time	Method
Patency of Treated Area	12 months	Maxillary Sinus Ostia of 27 patients analyzed.
Number of Participants With Device-related Adverse Events as a Measure of Safety	3 months

Trial Locations

Locations (5)

St. Elizabeth Medical Center; 🇺🇸 Boston, Massachusetts, United States

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States

Valley ENT; 🇺🇸 Tucson, Arizona, United States

St. Paul's Hospital, ENT Department; 🇨🇦 Vancouver, British Columbia, Canada

Charing Cross Hospital; 🇬🇧 London, United Kingdom