XprESS Registry Study
1 other identifier
interventional
175
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
October 8, 2020
CompletedOctober 27, 2020
October 1, 2020
1.7 years
April 29, 2010
September 15, 2020
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Assessments
Adverse event reporting as related to XprESS device or procedure
1 month after procedure
Secondary Outcomes (3)
Sino-Nasal Outcome Test (SNOT-20) at 1 Month
Baseline and 1 month after procedure
SNOT-20 at 6 Months
Baseline and 6 months post procedure
SNOT-20 at 12 Months
Baseline and 12 months post procedure
Other Outcomes (1)
Number of Sinuses Demonstrating Functional Patency
12 months post procedure
Study Arms (1)
XprESS Balloon Device
OTHERSinus dilation
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Sinus Center
San Antonio, Texas, 78006, United States
Related Publications (1)
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.
PMID: 23424023RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Clinical Research & Publications Manager
- Organization
- Stryker ENT
Study Officials
- STUDY CHAIR
Jeff Grebner
Entellus Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 4, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 27, 2020
Results First Posted
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share