Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
NCT ID: NCT07027267
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-08-05
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label
Treatment with the Spirair device as a treatment for medialization of the middle turbinates
Implantation of Spirair device into the middle turbinates
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.
TurbAlign
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery
Interventions
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Implantation of Spirair device into the middle turbinates
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.
TurbAlign
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject scheduled to undergo bilateral endoscopic sinus surgery
* Able to speak, read and understand English
* Willing and able to provide informed consent and comply with the study protocol
Exclusion Criteria
* Presence of significant concha bullosa, which requires surgical excision
* Presence of non-viable tissue at the implantation site
* Active infection at the implantation site
* Chronic nasal decongestant use (i.e. Afrin, etc)
* Recreational intra-nasal drug use within 12 months of enrollment
* Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
* Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
18 Years
70 Years
ALL
Yes
Sponsors
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Spirair, Inc
INDUSTRY
Responsible Party
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Locations
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Northwest Community Hospital
Arlington Heights, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
LSU Health Science Center
Shreveport, Louisiana, United States
Houston Methodist ENT Specialists
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT-004
Identifier Type: -
Identifier Source: org_study_id
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