SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Sinusitis Clinical Trial

Official title:

SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463279
• Other study ID #: SNS-006
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: December 11, 2016
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: SinuSys Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	St. Elizabeth Medical Center	Brighton	Massachusetts
United States	Colorado ENT	Denver	Colorado
United States	Upland ENT	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
SinuSys Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of treated target site	Patency assessed by investigator via endoscopic evaluation of the target site	Patency immediately post device expansion and removal	No
Secondary	Patency of treated target site	Patency assessed by investigator via endoscopic evaluation of the target site	1 month and 3 months	No
Secondary	Reports of sinus related adverse events during the 3 months follow-up period		up to 3 months	Yes