Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAiriver Medical, Inc.
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 groupsSponsors and collaborators
Source ClinicalTrials.gov