Deviated Nasal Septum
Conditions
Brief summary
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ 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.
Interventions
DEVICEENTact™ Septal Stapler
1 year aged septal staples
Sponsors
ENTrigue Surgical, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 is male, * subject not of child bearing age, * subject is surgically sterile, * subject is not pregnant per negative hCG test. * 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: * smoker, * severe drug abuser, * severe alcohol abuser. * Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical performance of aged ENTact™ Septal Staples | One week post op |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation of gross tissue appearance at implantation site(s) | One week post op |
| ENTact™ Septal Staple functionality based on maintained coaptation | One week post op |
Countries
United States
Outcome results
None listed