Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
NCT ID: NCT00896883
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2009-04-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Middle Turbinate Implant
Subjects to receive Middle Turbinate Implant
Middle Turbinate Implant
Middle Turbinate Implant placement at time of surgery and follow ups.
Interventions
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Middle Turbinate Implant
Middle Turbinate Implant placement at time of surgery and follow ups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
65 Years
ALL
No
Sponsors
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ENTrigue Surgical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald B Kuppersmith, MD
Role: PRINCIPAL_INVESTIGATOR
Texas ENT and Allergy
Locations
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Becker Nose and Sinus Center
Sewell, New Jersey, United States
Texas Sinus Center
Boerne, Texas, United States
Texas ENT and Allergy
College Station, Texas, United States
San Antonio Ear, Nose and Throat Research
San Antonio, Texas, United States
Countries
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Other Identifiers
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CSA2008-02
Identifier Type: -
Identifier Source: org_study_id