Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
175 participants
INTERVENTIONAL
2010-04-30
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XprESS Balloon Device
Sinus dilation
XprESS Balloon Device
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).
Interventions
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XprESS Balloon Device
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
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Inclusion Criteria
* 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
* History of primary ciliary dysfunction
* History of cystic fibrosis
* Known to be immunosuppressed
* Hemophilia
* Currently enrolled in another pre-approval investigational study
18 Years
ALL
No
Sponsors
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Entellus Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Grebner
Role: STUDY_CHAIR
Entellus Medical
Locations
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Texas Sinus Center
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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1677-001
Identifier Type: -
Identifier Source: org_study_id