A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery
Northwest Community Hospital
Arlington Heights, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
LSU Health Science Center
Shreveport, Louisiana, United States
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.
Time frame: 8 Weeks
Middle Turbinate Position Grade
Rate of avoidance of the middle turbinate lateralization at 4 and 8 weeks using Middle Turbinate Position Grade
Time frame: 4 and 8 weeks
Miller Synechia Score
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
Time frame: 4 weeks
Inflammation assessment
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
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Houston Methodist ENT Specialists
Houston, Texas, United States