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New nasal implant aims to prevent scarring after sinus surgery

NCT ID NCT07027267

Disease control Sponsor: Spirair, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a small, dissolvable implant called TurbAlign that is placed in the nose during sinus surgery. The goal is to keep the middle turbinate from shifting and causing scarring that blocks airflow. Fifty adults having sinus surgery will receive the implant and be followed for 8 weeks to see if it prevents complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TurbAlign bioabsorbable implant
What this could lead to
If successful, this implant could reduce the need for additional surgeries by preventing nasal scarring after sinus procedures.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The implant is new and its long-term benefits are unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sinus endoscopic surgery Turbinate

Contacts and locations

Locations

  • Houston Methodist ENT Specialists

    Houston, Texas, 77030, United States

  • LSU Health Science Center

    Shreveport, Louisiana, 71130, United States

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States