Implantation of Spirair device into the middle turbinatesTurbAlign
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
Study summary
A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* ≥18 to ≤ 75 years of age at time of consent
* Subject scheduled to undergo bilateral endoscopic sinus surgery
* Willing and able to provide informed consent and comply with the study protocol
Exclusion Criteria:
* History of removal of one or both middle turbinates
* 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
Primary outcome measure(s)
Miller Synechia Score — 8 Weeks Rate of lateral synechia formation resulting in occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 8 weeks.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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