Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Part of paid clinical trials in Brooklyn Park, Minnesota.

Sponsor
Airiver Medical, Inc.
Study ID
NCT07290140
Status
Not Yet 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

Start date
Mar 1, 2026
Status verified
Dec 2025
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 (1)

FacilityCityStateZIPSite coordinators
Airiver MedicalBrooklyn ParkMinnesota55428
Clinical Operation Director
[email protected]
6123108755

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By research site
Airiver Medical· Brooklyn Park, MN

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