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

ENTrigue Surgical

Status: Completed

Conditions: Nasal Septum

Study type: Observational

Funder types: Industry

Identifiers

NCT00740480

CSA 2008-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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
• 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

Trial design

25 participants in 1 patient group

Surgical

Description:

Adult population (ages 18-65) with clinically significant nasal septum deviation.