Skip to main content
OpenTrials
Completed

NCT Number: NCT01623050

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Paul's Hospital, ENT Department, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinusys Dilation System

Device

Sinuplasty

Primary outcomes

  1. Patency of Treated Area

    Time frame: Immediately post procedure

Secondary outcomes

  1. Patency of Treated Area

    Time frame: 3 months

    Maxillary Sinus Ostia Patency of 33 patients analyzed.

  2. Number of Participants With Device-related Adverse Events as a Measure of Safety

    Time frame: 3 months

  3. Patency of Treated Area

    Time frame: 6 months

    Maxillary Sinus Ostia Patency of 29 patients analyzed.

  4. Patency of Treated Area

    Time frame: 12 months

    Maxillary Sinus Ostia of 27 patients analyzed.

Sponsors and collaborators

Lead sponsor

SinuSys Corporation

Industry

Registry information

Official study title

SinuSys Patency of Maxillary Sinus Ostia Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2012
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.