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This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).
Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| • Treatment with the Airiver ESSpand DCB and ESS | Experimental | Subjects will have ESSpand DCB dilation of the ESS treated sinuses | |
| Treatment with ESS | Active Comparator | Subjects will have ESS treatment at target sinuses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airiver ESSpand DCB | Combination Product | The investigational procedure will be ESSpand DCB dilation of all surgically treated sinuses, including the resected ethmoid sinus cavities. Note: Prior to randomization to the investigational procedure, all subjects will undergo traditional ESS of their diseased sinuses. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety | Incidence of major adverse events (MAE) through 30 days post-index treatment. | 30 days post- index procedure |
| Primary efficacy endpoint | Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure. | 6 months post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Hypothesis tested clinical responder rate at 12 months | a responder is defined as a subject who has not undergone revision ESS, balloon sinus dilation, or any other procedural intervention, or received oral/systemic steroid or biologic therapy for CRS in the follow-up period, and with SNOT-22 score change from baseline (CFBL) by ≥8.9 points | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sr Clinical Operation Director | Contact | 6123250226 | myersj@airiver.com | |
| Chief Operation Officer | Contact | vajgrtp@airiver.com |
| Name | Affiliation | Role |
|---|---|---|
| Noem Cohen, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excel ENT | Recruiting | Birmingham | Alabama | 35244 | United States |
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| ESS | Procedure | traditional ESS treatment of diseased sinuses. |
|
| Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer | Grading 0 to 3, the higher grade indicates significant scarring and adhesion | 6 months |
| SENTA Clinica | Recruiting | San Diego | California | 92108 | United States |
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| Colorado ENT & Allergy | Recruiting | Colorado Springs | Colorado | 80923 | United States |
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| Physicians' Clinic of Iowa | Recruiting | Cedar Rapids | Iowa | 52403 | United States |
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| Advanced ENT | Recruiting | Louisville | Kentucky | 40220 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Dallas ENT | Recruiting | Dallas | Texas | 75244 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
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