Status:
COMPLETED
ENTact™ Septal Stapler Shelf Life Extension
Lead Sponsor:
ENTrigue Surgical, Inc.
Conditions:
Deviated Nasal Septum
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 approx...
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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00957502
Start Date
July 1 2009
End Date
February 1 2010
Last Update
August 23 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220