Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

NCT07290140 | Recruiting DMC FDA Device

• 1 other identifier: PR3056
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Hypothesis tested clinical responder rate at 12 months

  12 months

• Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer

  6 months

Study Arms (2)

• 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

Procedure: ESS

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.

Treatment with ESS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years
• Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
• Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
• Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
• Baseline SNOT-22 score ≥ 30
• Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
• Willing and able to provide written informed consent
• Willing and able to comply with all protocol follow up visits and assessments

You may not qualify if:

• Nasal cavity tumor (malignant or benign)
• Antrochoanal polyps
• Previous complete middle turbinate resection
• Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
• History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
• Concurrent condition requiring active chemotherapy and/or immunotherapy management
• Subjects whose symptoms are too severe to undergo ESS (e.g., temperature \>102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
• History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
• History of primary ciliary dyskinesia
• Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
• Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
• Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.
• Allergy or hypersensitivity to paclitaxel or structurally related compounds.
• Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.
• Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.

Sponsors & Collaborators

• Airiver Medical, Inc.: lead

Study Sites (10)

Excel ENT

Birmingham, Alabama, 35244, United States

RECRUITING

SENTA Clinica

San Diego, California, 92108, United States

RECRUITING

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

RECRUITING

Physicians' Clinic of Iowa

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Advanced ENT

Louisville, Kentucky, 40220, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Charleston ENT & Allergy

Charleston, South Carolina, 29406, United States

RECRUITING

MUSC - Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Dallas ENT

Dallas, Texas, 75244, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Study Officials

• Noem Cohen, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sr Clinical Operation Director

CONTACT

6123250226; myersj@airiver.com

Chief Operation Officer

CONTACT

vajgrtp@airiver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 18, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 28, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (10)