Back to resultsXprESS Registry Study
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XprESS Balloon Device
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis focused on measuring Sinusitis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
- Willing and able to provide consent
Exclusion Criteria:
- Known Samter's Triad
- History of primary ciliary dysfunction
- History of cystic fibrosis
- Known to be immunosuppressed
- Hemophilia
- Currently enrolled in another pre-approval investigational study
Sites / Locations
- Texas Sinus Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
XprESS Balloon Device
Arm Description
Sinus dilation
Outcomes
Primary Outcome Measures
Safety Assessments
Adverse event reporting as related to XprESS device or procedure
Secondary Outcome Measures
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
SNOT-20 at 6 Months
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
SNOT-20 at 12 Months
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01115309
Brief Title
XprESS Registry Study
Official Title
XprESS Registry Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (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 Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).
Detailed Description
Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.
One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
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
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XprESS Balloon Device
Arm Type
Other
Arm Description
Sinus dilation
Intervention Type
Device
Intervention Name(s)
XprESS Balloon Device
Intervention Description
Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
Primary Outcome Measure Information:
Title
Safety Assessments
Description
Adverse event reporting as related to XprESS device or procedure
Time Frame
1 month after procedure
Secondary Outcome Measure Information:
Title
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
Description
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Time Frame
Baseline and 1 month after procedure
Title
SNOT-20 at 6 Months
Description
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Time Frame
Baseline and 6 months post procedure
Title
SNOT-20 at 12 Months
Description
The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.
Time Frame
Baseline and 12 months post procedure
Other Pre-specified Outcome Measures:
Title
Number of Sinuses Demonstrating Functional Patency
Description
Functional patency of the sinus ostia originally treated with XprESS was assessed by the clinical site either by visual endoscopic evidence of a clear drainage path or radiographic evidence of a completely aerated sinus at 12-month follow-up for the first 50 patients treated in the study.
Time Frame
12 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
Willing and able to provide consent
Exclusion Criteria:
Known Samter's Triad
History of primary ciliary dysfunction
History of cystic fibrosis
Known to be immunosuppressed
Hemophilia
Currently enrolled in another pre-approval investigational study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Grebner
Organizational Affiliation
Entellus Medical
Official's Role
Study Chair
Facility Information:
Facility Name
Texas Sinus Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23424023
Citation
Brodner D, Nachlas N, Mock P, Truitt T, Armstrong M, Pasha R, Jung C, Atkins J. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. doi: 10.1002/alr.21156. Epub 2013 Feb 19.
Results Reference
result
Learn more about this trial
XprESS Registry Study
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