The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.
The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate: * surgical performance of the ENTact Septal Staple System * one week post op clinical evaluation of gross tissue appearance at implantation site(s) * ENTact™ Septal Staple functionality based on maintained coaptation
Study Type
OBSERVATIONAL
Enrollment
25
Good Samaritan Hospital
Cincinnati, Ohio, United States
Park Hudson Surgery Center
Bryan, Texas, United States
Physician's Ambulatory Surgery Center IV
San Antonio, Texas, United States
Coaptation (Tissue Approximation)
Complete tissue approximation at one week.
Time frame: One week post surgery
Tissue Reaction to Implant
None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.
Time frame: One week post surgery
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