Health TrialsbyHealthPanel

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

ConditionChronic Rhinosinusitis (CRS) With and Without Nasal Polyps
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    traditional ESS treatment of diseased sinuses.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: • Treatment with the Airiver ESSpand DCB and ESSExperimental treatment 0 interventions
Group B: Treatment with ESSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary safety

Incidence of major adverse events (MAE) through 30 days post-index treatment.

Time frame
30 days post- index procedure
2

Primary efficacy endpoint

Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure.

Time frame
6 months post-index procedure

Secondary outcomes

1

Hypothesis tested clinical responder rate at 12 months

a responder is defined as a subject who has not undergone revision ESS, balloon sinus dilation, or any other procedural intervention, or received oral/systemic steroid or biologic therapy for CRS in the follow-up period, and with SNOT-22 score change from baseline (CFBL) by ≥8.9 points

Time frame
12 months
2

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

Grading 0 to 3, the higher grade indicates significant scarring and adhesion

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Airiver Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now