Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

SinuSys

Status and phase: Completed; Phase 1

Conditions: Sinusitis

Treatments: Device: SinuSys Dilation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01623050

SNS-005

Details and patient eligibility

About

The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

Full description

A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Diagnosis of chronic maxillary sinusitis

Exclusion criteria

• Previous antrostomy
• Sinonasal tumours
• Cystic fibrosis
• History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
• Pregnant or breastfeeding females
• Currently participating in another drug or device study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

SinuSys Dilation System

Experimental group

Description:

Maxillary Sinus Dilation

Treatment:

Device: SinuSys Dilation System