- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00896883
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum (MTI)
August 21, 2012 updated by: ENTrigue Surgical, Inc.
A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
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 Principal Investigator determines clinical relevance.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Sewell, New Jersey, United States, 08080
- Becker Nose and Sinus Center
-
-
Texas
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Boerne, Texas, United States, 78006
- Texas Sinus Center
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College Station, Texas, United States, 77845
- Texas ENT and Allergy
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San Antonio, Texas, United States, 78229
- San Antonio Ear, Nose and Throat Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Middle Turbinate Implant
Subjects to receive Middle Turbinate Implant
|
Middle Turbinate Implant placement at time of surgery and follow ups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional performance of the MTI
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual tissue reaction to the Middle Turbinate Implant
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald B Kuppersmith, MD, Texas ENT and Allergy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 8, 2009
First Submitted That Met QC Criteria
May 11, 2009
First Posted (Estimate)
May 12, 2009
Study Record Updates
Last Update Posted (Estimate)
August 23, 2012
Last Update Submitted That Met QC Criteria
August 21, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSA2008-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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