Health Trials

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Airiver ESSpand DCB
  • ESS

Treatment groups

300 Participants
are divided into 2 treatment groups

Locations

8
Alabama
Excel ENT35244, Birmingham United States
California
SENTA Clinica92108, San Diego United States
Colorado
Colorado ENT & Allergy80923, Colorado Springs United States
Iowa
Physicians' Clinic of Iowa52403, Cedar Rapids United States

Sponsors and collaborators

Airiver Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov