ENTact™ Septal Stapler Shelf Life Extension

Completed · Not applicable

Conditions studied: Deviated Nasal Septum

In brief

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.

Key facts

Study ID

NCT00957502

Run by

ENTrigue Surgical, Inc.

People needed

5

Starts

2009-07-01

Expected to finish

2010-02-01

Last updated by the study team

2012-08-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not 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.
• 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.

You may not qualify if…

• 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.

Where it is running

• Good Samaritan Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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