SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

SinuSys

Status: Completed

Conditions: Sinusitis

Treatments: Device: Sinusys Dilation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02463279

SNS-006

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SinuSys Dilation System

Experimental group

Description:

Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)

Treatment:

Device: Sinusys Dilation System