Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ENTrigue Surgical, Inc.
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
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
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
