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NCT Number: NCT07027267

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sinus Endoscopic Surgery Turbinate

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Community Hospital, Arlington Heights, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of Spirair device into the middle turbinates

Device

The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.

Other names: TurbAlign

TurbAlign

Device

The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery

Primary outcomes

  1. Miller Synechia Score

    Time frame: 8 Weeks

    Rate of lateral synechia formation resulting in occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 8 weeks.

Secondary outcomes

  1. Middle Turbinate Position Grade

    Time frame: 4 and 8 weeks

    Rate of avoidance of the middle turbinate lateralization at 4 and 8 weeks using Middle Turbinate Position Grade

  2. Miller Synechia Score

    Time frame: 4 weeks

    Rate of lateral synechia formation resulting gin occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 4 weeks

  3. Inflammation assessment

    Time frame: 8 weeks

    Inflammation assessment of the gross tissue appearance at implantation site is assessed via live endoscopic video and graded I: None, II: Mild, III: Moderate, IV: Severe by investigator at 8 weeks

Sponsors and collaborators

Lead sponsor

Spirair, Inc

Industry

Registry information

Official study title

A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)

Acronym: Gaia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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