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

This study has been completed.
Information provided by (Responsible Party):
SinuSys Corporation Identifier:
First received: June 13, 2012
Last updated: October 30, 2014
Last verified: October 2014
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

Condition Intervention Phase
Sinusitis Device: SinuSys Dilation System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SinuSys Patency of Maxillary Sinus Ostia Study

Resource links provided by NLM:

Further study details as provided by SinuSys Corporation:

Primary Outcome Measures:
  • Patency of Treated Area [ Time Frame: Immediately post procedure ]

Secondary Outcome Measures:
  • Patency of Treated Area [ Time Frame: 3 months ]
    Maxillary Sinus Ostia Patency of 33 patients analyzed.

  • Number of Participants With Device-related Adverse Events as a Measure of Safety [ Time Frame: 3 months ]
  • Patency of Treated Area [ Time Frame: 6 months ]
    Maxillary Sinus Ostia Patency of 29 patients analyzed.

  • Patency of Treated Area [ Time Frame: 12 months ]
    Maxillary Sinus Ostia of 27 patients analyzed.

Enrollment: 36
Study Start Date: April 2012
Study Completion Date: September 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SinuSys Dilation System
Maxillary Sinus Dilation
Device: SinuSys Dilation System

Detailed 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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01623050

United States, Arizona
Valley ENT
Tucson, Arizona, United States, 85745
United States, California
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
United States, Massachusetts
St. Elizabeth Medical Center
Boston, Massachusetts, United States, 02135
Canada, British Columbia
St. Paul's Hospital, ENT Department
Vancouver, British Columbia, Canada, BC V6Z 1Y6
United Kingdom
Charing Cross Hospital
London, United Kingdom
Sponsors and Collaborators
SinuSys Corporation
Principal Investigator: Peter Catalano, MD St Elizabeth Medical Center
Principal Investigator: Amin Javer, MD St. Paul's Hospital
  More Information

Responsible Party: SinuSys Corporation Identifier: NCT01623050     History of Changes
Other Study ID Numbers: SNS-005
Study First Received: June 13, 2012
Results First Received: September 26, 2014
Last Updated: October 30, 2014

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases processed this record on September 21, 2017