Status:
COMPLETED
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
Lead Sponsor:
ENTrigue Surgical, Inc.
Conditions:
Sinusitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Princip...
Eligibility Criteria
Inclusion
- Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
- Subject is able to provide a signed informed consent form.
- Subject 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
- Subject does not meet inclusion criteria.
- Presence of non-viable tissue at the implantation site.
- History of septal perforation.
- History of polyps.
- Presence of concha bullosa.
- Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea.
- Subject is participating in a clinical trial which could affect the healing of the middle turbinate.
- Subject has uncontrolled diabetes.
- Subject is a:
- smoker
- severe drug abuser
- severe alcohol abuser
- Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00896883
Start Date
April 1 2009
End Date
May 1 2010
Last Update
August 23 2012
Active Locations (4)
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1
Becker Nose and Sinus Center
Sewell, New Jersey, United States, 08080
2
Texas Sinus Center
Boerne, Texas, United States, 78006
3
Texas ENT and Allergy
College Station, Texas, United States, 77845
4
San Antonio Ear, Nose and Throat Research
San Antonio, Texas, United States, 78229