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| Name | Class |
|---|---|
| NAMSA | OTHER |
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The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting sinus stent.
A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCEAN | Experimental | Application after nasal/sinus surgery |
|
| Steroid-eluting Sinus Stent | Active Comparator | Application after nasal/sinus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCEAN | Device | Biodegradable nasal dressing applied after sinus/nasal surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Serious Adverse Events | Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing. | Up to Day 25 |
| Endoscopic Assessment | Endoscopic assessment of wound healing to compare test-treated and control-treated cavities. | Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events | Assessment of all adverse events. | Up to Day 90 |
| Endoscopic Evaluation of Sinonasal Cavities | Endoscopic evaluation of sinonasal cavities for to evaluate wound healing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | United States | ||
| Emory University |
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Intra-patient study design comparing test-treated to control-treated cavities.
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| Steroid-eluting sinus stent |
| Device |
Applied after sinus/nasal surgery |
|
| Days 25 and 90 |
| Rate of post-operative interventions | Rate of post-operative interventions, including surgical intervention to separate adhesions, and/or oral steroid intervention, and/or biologics. | Up to Day 25 and Day 90 |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Louisiana State University Health at Shreveport | Shreveport | Louisiana | 71103 | United States |
| Centers for Advanced ENT Care | Towson | Maryland | 21204 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas Health | Houston | Texas | 77030 | United States |
| Ogden Clinic | Ogden | Utah | 84403 | United States |
| ENT Allergy & Associates | Puyallup | Washington | 98374 | United States |