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

NCT07027267 | Active Not Recruiting FDA Device

• 1 other identifier: CT-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Sinus Endoscopic Surgery; Turbinate

Keywords

Sinus surgery; FESS; middle turbinate; TurbAlign

Outcome Measures

Primary Outcomes (1)

• Miller Synechia Score

  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.

  8 Weeks

Secondary Outcomes (3)

• Middle Turbinate Position Grade

  4 and 8 weeks

• Miller Synechia Score

  4 weeks

• Inflammation assessment

  8 weeks

Study Arms (1)

Open-label

EXPERIMENTAL

Treatment with the Spirair device as a treatment for medialization of the middle turbinates

Device: Implantation of Spirair device into the middle turbinates; Device: TurbAlign

Interventions

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.

Also known as: TurbAlign

Open-label

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

Open-label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spirair, Inc: lead

Study Sites (5)

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

LSU Health Science Center

Shreveport, Louisiana, 71130, United States

Location

Houston Methodist ENT Specialists

Houston, Texas, 77030, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 18, 2025
• Study Start: August 4, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)