Back to resultsSinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
United States
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 CRS
- Subject in in need of frontal recess and/or sphenoid sinus dilation
Exclusion Criteria:
- Pregnant or breastfeeding females
- Previous treatment site intervention
- Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
Sites / Locations
- Upland ENT
- Colorado ENT
- St. Elizabeth Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SinuSys Dilation System
Arm Description
Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)
Outcomes
Primary Outcome Measures
Patency of treated target site
Patency assessed by investigator via endoscopic evaluation of the target site
Secondary Outcome Measures
Patency of treated target site
Patency assessed by investigator via endoscopic evaluation of the target site
Reports of sinus related adverse events during the 3 months follow-up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02463279
Brief Title
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
Official Title
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
March 2016 (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 goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
Detailed Description
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SinuSys Dilation System
Arm Type
Experimental
Arm Description
Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)
Intervention Type
Device
Intervention Name(s)
Sinusys Dilation System
Intervention Description
Dilation of frontal recess and/or sphenoid sinus ostia
Primary Outcome Measure Information:
Title
Patency of treated target site
Description
Patency assessed by investigator via endoscopic evaluation of the target site
Time Frame
Patency immediately post device expansion and removal
Secondary Outcome Measure Information:
Title
Patency of treated target site
Description
Patency assessed by investigator via endoscopic evaluation of the target site
Time Frame
1 month and 3 months
Title
Reports of sinus related adverse events during the 3 months follow-up period
Time Frame
up to 3 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 CRS
Subject in in need of frontal recess and/or sphenoid sinus dilation
Exclusion Criteria:
Pregnant or breastfeeding females
Previous treatment site intervention
Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome Hester, MD
Organizational Affiliation
SinuSys Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Upland ENT
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Colorado ENT
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
St. Elizabeth Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
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