SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Not Applicable

Completed

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

• Registration Number: NCT02463279
• Lead Sponsor: SinuSys Corporation

Brief Summary

The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

Detailed Description

A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2015-10
• Study Completion: 2016-03
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-11
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of CRS
• Subject in in need of frontal recess and/or sphenoid sinus dilation

Exclusion Criteria

• Pregnant or breastfeeding females
• Previous treatment site intervention
• Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SinuSys Dilation System	Sinusys Dilation System	Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)

Primary Outcome Measures

Name	Time	Method
Patency of treated target site	Patency immediately post device expansion and removal	Patency assessed by investigator via endoscopic evaluation of the target site

Secondary Outcome Measures

Name	Time	Method
Patency of treated target site	1 month and 3 months	Patency assessed by investigator via endoscopic evaluation of the target site
Reports of sinus related adverse events during the 3 months follow-up period	up to 3 months

Trial Locations

Locations (3)

Upland ENT; 🇺🇸 Upland, California, United States

Colorado ENT; 🇺🇸 Denver, Colorado, United States

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