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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle Turbinate Implant | Experimental | Subjects to receive Middle Turbinate Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle Turbinate Implant | Device | Middle Turbinate Implant placement at time of surgery and follow ups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional performance of the MTI | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Visual tissue reaction to the Middle Turbinate Implant | 1 month |
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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:
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:
Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Ronald B Kuppersmith, MD | Texas ENT and Allergy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Becker Nose and Sinus Center | Sewell | New Jersey | 08080 | United States | ||
| Texas Sinus Center |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| Boerne |
| Texas |
| 78006 |
| United States |
| Texas ENT and Allergy | College Station | Texas | 77845 | United States |
| San Antonio Ear, Nose and Throat Research | San Antonio | Texas | 78229 | United States |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |