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

Launched by SPIRAIR, INC · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, temporary implant called TurbAlign™ that is designed to help patients who are having sinus surgery. After surgery, the middle turbinate—a small, curved bone inside the nose—can sometimes stick too close to the side wall of the nose, which may cause problems with healing or breathing. TurbAlign™ is a special implant that gently holds the middle turbinate in the right place and then naturally dissolves over time, helping to improve recovery after sinus surgery.

The study is looking for adults aged 18 to 70 who are scheduled to have sinus surgery on both sides of their nose and who can understand and agree to participate in the study. People who have had part or all of their middle turbinate removed before, have certain nasal conditions, or have active infections may not be eligible. Participants will receive the TurbAlign™ implant during their surgery and will be monitored to see how safe and effective it is. This study is not yet recruiting, but if you qualify, joining could help improve care for others having sinus surgery in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥18 to ≤ 70 years of age at time of consent
• • 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:
• • 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