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NCT02463279 Clinical Trial

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
Secondary ID
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

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
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