Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spirair, Inc
To evaluate the safety and effectiveness of the Spirair implant as a primary treatment to achieve medialization of the middle turbinate after functional endoscopic sinus surgery.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥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
You may not be if
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
Clareo Health | Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
