Chronic Rhinosinusitis (CRS) With and Without Nasal PolypsRESTORE-2 RCTNCT07290140
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
A study testing Airiver ESSpand DCB and ESS in people with Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by Airiver Medical, Inc. at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- What is being tested?
- Airiver ESSpand DCB and ESS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Jun 2026to 1 Mar 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
- Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.
- Subject has a history of inability to tolerate nasal endoscopy
- Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
- Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
- Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.
- Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.
- Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
- Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents.
- Subject whose study index procedure is aborted for any reason
- Life expectancy <2 years
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chief Operation Officer contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Excel ENT
Birmingham, Alabama, 35244
Brittany Cope, 256-322-1553, bcope@medovationresearch.com
Chris Davis, MD
- Recruiting
Physicians' Clinic of Iowa
Cedar Rapids, Iowa, 52403
Cassidy Holub, 319-247-3474, CMHOLUB@PCOFIOWA.COM
Thomas Heineman, MD
- Recruiting
Charleston ENT & Allergy
Charleston, South Carolina, 29406
Britney Ragoonath, (843) 766-7103, bragoonath@charlestonent.com
Erik Swanson, MD
- Recruiting
MUSC - Medical University of South Carolina
Charleston, South Carolina, 29425
Shaun Nguyen, MD, (843)792-1356, nguyensh@musc.edu
Rodney Schlosser, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Elena Squire, 434-243-3607, EM8ZK@uvahealth.org
Jose Mattos, MD
- Recruiting
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
Mary Zapalac, 719-867-7889, mzapalac@coloradoent.com
Bryan Davis, MD
- Recruiting
Dallas ENT
Dallas, Texas, 75244
Mounica Anumala, 214-483-9933, manumala@ten20medical.com
Rajiv Pandit, MD
- Recruiting
Advanced ENT
Louisville, Kentucky, 40220
Rhonda Dase, 502-399-1885 ext. 80071, rdase@advancedentandallergy.com
Andrew Gould, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pannda Sharma, 215-614-0036, pranndas@pennmedicine.upenn.edu
Noam Cohen, MD
- Recruiting
SENTA Clinica
San Diego, California, 92108
Alen Putros, 619-977-9873, aputrosent@gmail.com
Brian Weeks, MD
About this study
Official title: A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects
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).
Read the detailed description
Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.
- Being tested
- Airiver ESSpand DCB, ESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airiver ESSpand DCBCombination 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.
ESSProcedure or surgery
traditional ESS treatment of diseased sinuses.
| Study group | Role | What they receive |
|---|---|---|
| • 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 Receives: Procedure: ESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety
Incidence of major adverse events (MAE) through 30 days post-index treatment.
Measured: 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.
Measured: 6 months post-index procedure
Secondary outcomes (2)
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
Measured: 12 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jun 2026
- Primary completion28 Mar 2028 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS) With and Without Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Airiver Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noem Cohen, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290140
- Sponsor's protocol ID
- PR3056
- Acronym
- RESTORE-2 RCT
- Status last verified
- Jul 2026
- First submitted
- 8 Dec 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided