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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01623050
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : October 1, 2014
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
SinuSys Corporation

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

Condition or disease Intervention/treatment Phase
Sinusitis Device: SinuSys Dilation System Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SinuSys Patency of Maxillary Sinus Ostia Study
Study Start Date : April 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: SinuSys Dilation System
Maxillary Sinus Dilation
 Device: SinuSys Dilation System
Sinuplasty


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

Secondary Outcome Measures :
  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.


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623050


Locations
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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
Investigators
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Principal Investigator: Peter Catalano, MD St Elizabeth Medical Center
Principal Investigator: Amin Javer, MD St. Paul's Hospital
More Information
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Responsible Party: SinuSys Corporation
ClinicalTrials.gov Identifier: NCT01623050    
Other Study ID Numbers: SNS-005
First Posted: June 19, 2012    Key Record Dates
Results First Posted: October 1, 2014
Last Update Posted: November 5, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Sinusitis
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
 Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases