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

Condition(s) targeted: Nasal Septum

Phase: N/A

Status: Recruiting

Sponsored by: ENTrigue Surgical, Inc.

Official(s) and/or principal investigator(s):
Gabriele G Niederauer, Ph.D., Study Director, Affiliation: ENTrigue Surgical, Inc.

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.

Official title: A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties

Study design: Case-Only, Prospective

Primary outcome: Complete coaptation at one week.

Secondary outcome:

One week visual tissue reaction to implant

Intraoperative performance

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Physician's Ambulatory Surgery Center IV, San Antonio, Texas 78258, United States; Recruiting
Monica Moreno, Phone: 830-816-3838, Email: monicasmoreno@gmail.com
James H Atkins, MD, Principal Investigator
Charles Biediger, MD, Sub-Investigator

Park Hudson Surgery Center, Bryan, Texas 77802, United States; Recruiting
Nellie Minneman, Phone: 979-693-6000
Lisa Valigura, Phone: 979-693-6000, Email: lvaligura@texasentandallergy.com
Ronald B Kuppersmith, MD, Principal Investigator
Andrew L De Jong, MD, Sub-Investigator

Starting date: April 2008
Ending date: September 2008
Last updated: August 22, 2008