Sinus Endoscopic Surgery, Turbinate
Conditions
Keywords
Sinus surgery, FESS, middle turbinate, TurbAlign
Brief summary
A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
Detailed 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.
Interventions
DEVICEImplantation of Spirair device into the middle turbinates
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.
DEVICETurbAlign
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery
Sponsors
Spirair, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Miller Synechia Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Middle Turbinate Position Grade | 4 and 8 weeks | Rate of avoidance of the middle turbinate lateralization at 4 and 8 weeks using Middle Turbinate Position Grade |
| Miller Synechia Score | 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 |
| Inflammation assessment | 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 |
Countries
United States
Outcome results
None listed