SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

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 Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Device: Sinusys Dilation System

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Upland, California, United States, 91786
      • Upland ENT
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado ENT
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • St. Elizabeth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SinuSys Dilation System; Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)	Device: Sinusys Dilation System; Dilation of frontal recess and/or sphenoid sinus ostia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SinuSys Corporation
• Investigators: Study Director: Jerome Hester, MD, SinuSys Chief Medical Officer

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 11, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: SNS-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No