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The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.
MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MediENT | Experimental | Right or left sinus cavity where MediENT will be place after randomization. |
|
| MeroPack | Active Comparator | Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MediENT | Device | MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT |
| Measure | Description | Time Frame |
|---|---|---|
| Miller synechia score at 8 weeks | Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator) | 8 weeks post endoscopic sinus surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Miller Score at 4 & 8 weeks |
| 4 & 8 weeks post endoscopic sinus surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California ENT Medical Group | Fresno | California | 93720 | United States | ||
| Colorado ENT & Allergy |
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| MeroPack | Device | MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT |
|
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| ENT Associates of Texas | McKinney | Texas | 75079 | United States |
| Ear, Nose & Throat Clinics of San Antonio | San Antonio | Texas | 78229 | United States |