SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: October 2015

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).

Interventions

• Device: Sinusys Dilation System
  • Dilation of frontal recess and/or sphenoid sinus ostia

Arms, Groups and Cohorts

• Experimental: SinuSys Dilation System
  • Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)

Clinical Trial Outcome Measures

Primary Measures

• Patency of treated target site
  • Time Frame: Patency immediately post device expansion and removal
  • Patency assessed by investigator via endoscopic evaluation of the target site

Secondary Measures

• Patency of treated target site
  • Time Frame: 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
  • Time Frame: up to 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • SinuSys Corporation
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Jerome Hester, MD, Study Director, SinuSys Chief Medical Officer