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This study is a prospective, limited-use evaluation of the ENTactâ„¢ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTactâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One year aged staples | Experimental | Subjects implanted with sterile staples aged to approximately one year. |
|
| 18 month aged staples | Experimental | Subjects implanted with sterile staples aged to approximately 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENTactâ„¢ Septal Stapler | Device | 1 year aged septal staples |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance of aged ENTactâ„¢ Septal Staples | One week post op |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of gross tissue appearance at implantation site(s) | One week post op | |
| ENTactâ„¢ Septal Staple functionality based on maintained coaptation | One week post op |
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Inclusion Criteria:
Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
Patient is able to provide a signed informed consent form.
Patient will agree to comply with all study related procedures.
Subject is not pregnant at this time by confirmation of one of the following:
Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
Exclusion Criteria:
Patients who have had previous septoplasty
Patients with uncontrolled diabetes
Presence of infection at the study site
Subject is a:
Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Tami, MD | Good Samaritan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
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| ENTactâ„¢ Septal Stapler |
| Device |
18 Month Aged Staples |
|