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

Completed

Brief Summary: 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: 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

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Coaptation (Tissue Approximation)	One week post surgery	Complete tissue approximation at one week.

Secondary Outcome Measures

Name	Time	Method
Tissue Reaction to Implant	One week post surgery	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.

Locations (3): Physician's Ambulatory Surgery Center IV
🇺🇸
San Antonio, Texas, United States
Good Samaritan Hospital
🇺🇸
Cincinnati, Ohio, United States
Park Hudson Surgery Center
🇺🇸
Bryan, Texas, United States