Active — Not RecruitingNot Applicable

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

United States50 participantsStarted 2025-08-04

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Miller Synechia Score

Timeframe: 8 Weeks

Trial details

NCT IDNCT07027267

SponsorSpirair, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-05

View on ClinicalTrials.gov More Sinus Endoscopic Surgery trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.