Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery

Running, not enrolling · Not applicable

Conditions studied: Sinus Endoscopic Surgery, Turbinate

In brief

A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery

Key facts

Study ID

NCT07027267

Run by

Spirair, Inc

People needed

50

Starts

2025-08-04

Expected to finish

2026-07-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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