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

Spirair

Status

Not yet enrolling

Conditions

Turbinate

Sinus Endoscopic Surgery

Treatments

Device: Implantation of Spirair device into the middle turbinates

Device: TurbAlign

Study type

Interventional

Funder types

Industry

Identifiers

NCT07027267

CT-004

Details and patient eligibility

About

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

Full description

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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