Status:
COMPLETED
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
Lead Sponsor:
ENTrigue Surgical, Inc.
Conditions:
Nasal Septum
Eligibility:
All Genders
18-65 years
Brief Summary
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.
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 remo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00740480
Start Date
April 1 2008
End Date
February 1 2009
Last Update
August 25 2009
Active Locations (3)
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1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
2
Park Hudson Surgery Center
Bryan, Texas, United States, 77802
3
Physician's Ambulatory Surgery Center IV
San Antonio, Texas, United States, 78258