ENTact™ Septal Stapler Shelf Life Extension (SSLE)

ENTrigue Surgical

Status

Completed

Conditions

Deviated Nasal Septum

Treatments

Device: ENTact™ Septal Stapler

Study type

Interventional

Funder types

Industry

Identifiers

NCT00957502

CSA2009-03

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.