Back to resultsSafety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Primary Purpose
Sinusitis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SinuSys Dilation System
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis
Eligibility 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
Sites / Locations
- Valley ENT
- Palo Alto Medical Foundation
- St. Elizabeth Medical Center
- St. Paul's Hospital, ENT Department
- Charing Cross Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SinuSys Dilation System
Arm Description
Maxillary Sinus Dilation
Outcomes
Primary Outcome Measures
Patency of Treated Area
Secondary Outcome Measures
Patency of Treated Area
Maxillary Sinus Ostia Patency of 33 patients analyzed.
Number of Participants With Device-related Adverse Events as a Measure of Safety
Patency of Treated Area
Maxillary Sinus Ostia Patency of 29 patients analyzed.
Patency of Treated Area
Maxillary Sinus Ostia of 27 patients analyzed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01623050
Brief Title
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Official Title
SinuSys Patency of Maxillary Sinus Ostia Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SinuSys Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SinuSys Dilation System
Arm Type
Experimental
Arm Description
Maxillary Sinus Dilation
Intervention Type
Device
Intervention Name(s)
SinuSys Dilation System
Intervention Description
Sinuplasty
Primary Outcome Measure Information:
Title
Patency of Treated Area
Time Frame
Immediately post procedure
Secondary Outcome Measure Information:
Title
Patency of Treated Area
Description
Maxillary Sinus Ostia Patency of 33 patients analyzed.
Time Frame
3 months
Title
Number of Participants With Device-related Adverse Events as a Measure of Safety
Time Frame
3 months
Title
Patency of Treated Area
Description
Maxillary Sinus Ostia Patency of 29 patients analyzed.
Time Frame
6 months
Title
Patency of Treated Area
Description
Maxillary Sinus Ostia of 27 patients analyzed.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Catalano, MD
Organizational Affiliation
St Elizabeth Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amin Javer, MD
Organizational Affiliation
St. Paul's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley ENT
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Palo Alto Medical Foundation
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
St. Elizabeth Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
St. Paul's Hospital, ENT Department
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
BC V6Z 1Y6
Country
Canada
Facility Name
Charing Cross Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
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