Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Correction of NSD with Nasal Septal Strap implant
Breathe Clear Institute
Torrance, California, United States
Specialty Physicians
Bethlehem, Pennsylvania, United States
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
Feasibility of implantation and durability of Implant through the healing process
Time frame: 24 months
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