Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties

Conditions
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Nasal Septum

Participation Criteria
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Eligibility Criteria
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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 Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery Patient does not plan on becoming pregnant and is not breast feeding during the course of the study Exclusion Criteria: Patients who do not meet the inclusion criteria Patients who have had previous septoplasty Patients with uncontrolled diabetes Presence of infection at the site Smokers and severe drug and alcohol abusers Patients with autoimmune disease deemed clinically significant by Principal Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical<br>Adult population (ages 18-65) with clinically significant nasal septum deviation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coaptation (Tissue Approximation) | Complete tissue approximation at one week. | One week post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One week post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaluation, ENTact™, Septal, Staple, System, tissue, approximation, during, septoplasties