This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
1 year aged septal staples
18 Month Aged Staples
Good Samaritan Hospital
Cincinnati, Ohio, United States
Clinical performance of aged ENTact™ Septal Staples
Time frame: One week post op
Clinical evaluation of gross tissue appearance at implantation site(s)
Time frame: One week post op
ENTact™ Septal Staple functionality based on maintained coaptation
Time frame: One week post op
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