Back to resultsTrans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XprESS Multi-Sinus Dilation Tool
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis focused on measuring Sinusitis, Sinus balloon dilation patients
Eligibility Criteria
Inclusion Criteria:
- Be at least age 18 years old or older.
- Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
- Have a sinus CT scan within 12 months of the procedure date.
- Be able and willing to provide consent.
- Be willing to comply with the protocol requirements.
Exclusion Criteria:
- Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
- Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
- Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
- Have presence of features consistent with sinus fungal disease.
- Be allergic to nickel or barium sulfate.
- Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Sites / Locations
- Entellus Medical
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
XprESS Multi-Sinus Dilation Tool
Arm Description
Balloon sinus dilation
Outcomes
Primary Outcome Measures
Change in SNOT-20 Score
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Secondary Outcome Measures
Revision Sinus Surgery
The number of participants who require revision sinus surgery to address continuing sinus symptoms.
Number of Participants With Serious Device and/or Procedure-related Adverse Events
Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01612780
Brief Title
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Official Title
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entellus Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
Detailed Description
This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Sinusitis, Sinus balloon dilation patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XprESS Multi-Sinus Dilation Tool
Arm Type
Experimental
Arm Description
Balloon sinus dilation
Intervention Type
Device
Intervention Name(s)
XprESS Multi-Sinus Dilation Tool
Other Intervention Name(s)
Sinus balloon dilation
Intervention Description
Sinus balloon dilation
Primary Outcome Measure Information:
Title
Change in SNOT-20 Score
Description
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Time Frame
Baseline and 1-year post procedure
Secondary Outcome Measure Information:
Title
Revision Sinus Surgery
Description
The number of participants who require revision sinus surgery to address continuing sinus symptoms.
Time Frame
1-year post procedure
Title
Number of Participants With Serious Device and/or Procedure-related Adverse Events
Description
Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Time Frame
Through 1-year post procedure follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least age 18 years old or older.
Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
Have a sinus CT scan within 12 months of the procedure date.
Be able and willing to provide consent.
Be willing to comply with the protocol requirements.
Exclusion Criteria:
Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
Have presence of features consistent with sinus fungal disease.
Be allergic to nickel or barium sulfate.
Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Facility Information:
Facility Name
Entellus Medical
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55447
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24598043
Citation
Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14.
Results Reference
result
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Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
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