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

Completed

Conditions studied: Nasal Septum

In brief

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.

Key facts

Study ID

NCT00740480

Run by

ENTrigue Surgical, Inc.

People needed

25

Starts

2008-04-01

Expected to finish

2009-02-01

Last updated by the study team

2009-08-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify 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

You may not qualify if…

• 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

Where it is running

• Good Samaritan Hospital — Cincinnati, Ohio, United States
• Park Hudson Surgery Center — Bryan, Texas, United States
• Physician's Ambulatory Surgery Center IV — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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