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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SinuSys Corporation
ClinicalTrials.gov Identifier:
NCT01623050
First received: June 13, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SinuSys Patency of Maxillary Sinus Ostia Study

Further study details as provided by SinuSys Corporation:

Primary Outcome Measures:
  • Patency of treated area [ Time Frame: Immediately post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patency of treated area [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Number of participants with Adverse Events as a measure of Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: August 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: SinuSys Dilation System
Sinuplasty

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01623050

Locations
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
  More Information

No publications provided

Responsible Party: SinuSys Corporation
ClinicalTrials.gov Identifier: NCT01623050     History of Changes
Other Study ID Numbers: SNS-005
Study First Received: June 13, 2012
Last Updated: March 6, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on September 15, 2014