Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Airiver Medical, Inc.
Study ID
NCT07290140
Status
Recruiting
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Conditions

  • Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • ESS — PROCEDURE
    traditional ESS treatment of diseased sinuses.

Study Details

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).

Key Dates

First listed
Dec 18, 2025
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Mar 28, 2028
Completion
Mar 1, 2031

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: • Treatment with the Airiver ESSpand DCB and ESS
    Subjects will have ESSpand DCB dilation of the ESS treated sinuses
  • Active Comparator: Treatment with ESS
    Subjects will have ESS treatment at target sinuses

Primary Outcome Measure

Primary safety [ Time Frame: 30 days post- index procedure ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Excel ENTBirminghamAlabama35244
Brittany Cope
[email protected]
256-322-1553
Chris Davis, MD (PRINCIPAL_INVESTIGATOR)
SENTA ClinicaSan DiegoCalifornia92108
Alen Putros
[email protected]
619-977-9873
Brian Weeks, MD (PRINCIPAL_INVESTIGATOR)
Colorado ENT & AllergyColorado SpringsColorado80923
Mary Zapalac
[email protected]
719-867-7889
Bryan Davis, MD (PRINCIPAL_INVESTIGATOR)
Physicians' Clinic of IowaCedar RapidsIowa52403
Cassidy Holub
[email protected]
319-247-3474
Thomas Heineman, MD (PRINCIPAL_INVESTIGATOR)
Advanced ENTLouisvilleKentucky40220
Rhonda Dase
[email protected]
502-399-1885
Andrew Gould, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Pannda Sharma
[email protected]
215-614-0036
Noam Cohen, MD (PRINCIPAL_INVESTIGATOR)
Dallas ENTDallasTexas75244
Mounica Anumala
[email protected]
214-483-9933
Rajiv Pandit, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Elena Squire
[email protected]
434-243-3607
Jose Mattos, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Excel ENT· Birmingham, ALSENTA Clinica· San Diego, CAColorado ENT & Allergy· Colorado Springs, COPhysicians' Clinic of Iowa· Cedar Rapids, IAAdvanced ENT· Louisville, KYUniversity of Pennsylvania· Philadelphia, PA

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