Chronic RhinosinusitisEarly Phase 1NCT05883462
Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
A Early Phase 1 study testing Airiver Nasal Drug Coated Balloon (DCB) Catheter. in people with Chronic Rhinosinusitis, run by Airiver Medical, Inc. at 1 site in Paraguay.
Trial summary
It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP. Participants will receive AIRIVER Nasal drug-coated balloon treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Airiver Nasal Drug Coated Balloon (DCB) Catheter.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteParaguay
- Study dates
- 7 Jun 2023to 30 Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Pediatric CRS (PCRS)
- Acute bacterial sinusitis (ABRS), acute rhinosinusitis (ARS), or mycetoma and invasive fungal sinusitis
- Malignancy
- Experienced a cerebrospinal fluid (CSF) leak in prior skull-based dehiscence
- Symptomatic without positive CT findings or an asymptomatic
- Subjects whose symptoms are too severe (eg, temperature >102.58F or extrasinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
Show all 21Show fewer
- Primary ciliary dyskinesia (PCD)
- Unable to have nasal cavity examination due to septal deviation or spur. Participants who had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NP
- Have evidence of significant baseline mucosal injury, ulceration, or erosion (eg, exposed cartilage, perforation) on baseline nasal examination
- Purulent nasal infection, or upper respiratory tract infection within 2 weeks before the screening visit. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution
- Allergy or hypersensitivity to any excipients and paclitaxel.
- Patient has an inability to tolerate endoscopy
- Suffering or recovering from COVID-19 (Fully recovered Covid-19 patients is not excluded)
- Study subject has any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma
- Subjects with abnormal screening laboratory/imaging test results that compromise the ability to assess the benefits/risks (eg, abnormal ECG)
- Pregnancy or planning on pregnant during the first 12 months of enrollment in the study
- Life expectancy <1 year
- Patient is currently enrolled in other current investigational studies. Participation in studies for products approved in the US are not considered investigational.
- Lack of informed consent
- Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Trial of Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps
It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP.
Participants will receive AIRIVER Nasal drug-coated balloon treatment.
Read the detailed description
Paclitaxel coated balloon is designed to offer both mechanical dilation of nasal obstruction and local drug effect for underlying inflammatory disorder and cell hyperplasia. It is hypothesized that Airiver Nasal drug-coated balloon (DCB) will improve patient outcome and as an adjunct to standard of care, will improve nasal patency than the standard of care alone. This is a prospective, single arm, first in human (FIH) study.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Airiver Nasal Drug Coated Balloon (DCB) Catheter.
- Keywords
- recurrent, CRS with nasal polyps, CRS without nasal polyps
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airiver Nasal Drug Coated Balloon (DCB) Catheter.Combination product
The balloon is coated with a paclitaxel drug (3.5ug/mm2).
| Study group | Role | What they receive |
|---|---|---|
| Single arm treated by Airiver Nasal DCB | Experimental | Subjects with recurrent symptomatic nasal obstruction will be treated by Airiver Nasal Drug Coated Balloon (DCB) Catheter at the index procedure. The balloon is coated with a paclitaxel drug (3.5ug/mm2). Receives: Combination Product: Airiver Nasal Drug Coated Balloon (DCB) Catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety: Freedom from major device related adverse events (MADE) post index procedure assessed by the proportion of subjects free from the primary safety event through 30 days.
Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. MADE is defined as: 1) Cerebrospinal fluid (CSF) leak, 2) Severe epistaxis (nasal bleeding) requiring intervention other than packing, 3) Eye complication requiring surgical treatment, 4) Paclitaxel related nasal mucosal disorder.
Measured: 30 days
Primary efficacy: Freedom from target lesion reintervention due to recurrence of CRS without nasal polyposis or CRS with nasal polyposis (retuning to baseline symptoms or worse) through 6 months.
assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR.
Measured: 6 months
Secondary outcomes (9)
Incidence of, and time to symptom-driven reintervention
assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR
Measured: 12 months
Change in patient reported 22-item Sino-Nasal Outcome Test (SNOT-22) from the baseline
Total SNOT 22 score is between 0 to 110. Higher scores indicate worse rhinosinusitis.
Measured: 12 months
Change in Lund-Kennedy Endoscopic Scores from the baseline
The scores range is from 0 to 20. Higher scores indicate worse observed disease.
Measured: 12 months
Change in Lund-Mackay computed tomography (LMK-CT) score from the baseline
The score range is from 0 to 24. Higher scores indicate worse disease severity.
Measured: 12 months.
Change of Health-related quality -of- life (HRQL) from the baseline (Euro-QOL-5D questionnaire)
The EQ-5D essentially consists of 2 parts: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS. The EQ VAS 'thermometer' has scales of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom.
Measured: 12 months
Change in sense of smell using the University of Pennsylvania Smell Identification Test (UPSIT) from the baseline
The score range is between 0-40. Higher scores indicate better smell function.
Measured: 12 months
Clinical pharmacokinetics of paclitaxel in 15 subjects
Blood samples will be collected at baseline and post procedure at pre-designated time points and assessed for plasma paclitaxel concentrations.
Measured: 10 days
Change in Asthma Control Questionnaire-6 (ACQ-5) Scores from baseline for subjects with comorbid asthma
A score of 0-6 is assigned to values for each criterion. The total ACQ score is the mean value calculated after adding the individual scores for each criterion. In general, patients with a score below 1.0 are likely to have adequately controlled asthma, above 1.0 their asthma is not likely to be well-controlled.
Measured: 12 months
Nasal DCB performance evaluation in index procedures
Device Performance will be assessed using a rating scale (1-5) to evaluate seven aspects of the test article. Higher scores indicate better performance.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start7 Jun 2023
- Primary completion21 Oct 2025
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Airiver Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Coral Leticia Benítez Insaurralde, MD, Principal investigator, Sanatorio Americano Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883462
- Sponsor's protocol ID
- RESTORE-1
- Status last verified
- Dec 2025
- First submitted
- 19 May 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps
- ClinicalTrials.gov ID
- NCT05883462
- Acronym / sponsor ID
- RESTORE-1
- Conditions
- Chronic Rhinosinusitis
- Keywords
- recurrent, CRS with nasal polyps, CRS without nasal polyps
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Airiver Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP.
Participants will receive AIRIVER Nasal drug-coated balloon treatment.
Detailed description
Paclitaxel coated balloon is designed to offer both mechanical dilation of nasal obstruction and local drug effect for underlying inflammatory disorder and cell hyperplasia. It is hypothesized that Airiver Nasal drug-coated balloon (DCB) will improve patient outcome and as an adjunct to standard of care, will improve nasal patency than the standard of care alone. This is a prospective, single arm, first in human (FIH) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm treated by Airiver Nasal DCB | Experimental | Combination Product: Airiver Nasal Drug Coated Balloon (DCB) Catheter.Subjects with recurrent symptomatic nasal obstruction will be treated by Airiver Nasal Drug Coated Balloon (DCB) Catheter at the index procedure. The balloon is coated with a paclitaxel drug (3.5ug/mm2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Pediatric CRS (PCRS)
- Acute bacterial sinusitis (ABRS), acute rhinosinusitis (ARS), or mycetoma and invasive fungal sinusitis
- Malignancy
- Experienced a cerebrospinal fluid (CSF) leak in prior skull-based dehiscence
- Symptomatic without positive CT findings or an asymptomatic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airiver Nasal Drug Coated Balloon (DCB) Catheter.The balloon is coated with a paclitaxel drug (3.5ug/mm2). | Combination product | Single arm treated by Airiver Nasal DCB |
Primary outcome
Primary safety: Freedom from major device related adverse events (MADE) post index procedure assessed by the proportion of subjects free from the primary safety event through 30 days.
Time frame: 30 days
Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. MADE is defined as: 1) Cerebrospinal fluid (CSF) leak, 2) Severe epistaxis (nasal bleeding) requiring intervention other than packing, 3) Eye complication requiring surgical treatment, 4) Paclitaxel related nasal mucosal disorder.
Primary efficacy: Freedom from target lesion reintervention due to recurrence of CRS without nasal polyposis or CRS with nasal polyposis (retuning to baseline symptoms or worse) through 6 months.
Time frame: 6 months
assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR.
9 secondary outcomes
Incidence of, and time to symptom-driven reintervention
Time frame: 12 months
Change in patient reported 22-item Sino-Nasal Outcome Test (SNOT-22) from the baseline
Time frame: 12 months
Change in Lund-Kennedy Endoscopic Scores from the baseline
Time frame: 12 months
Change in Lund-Mackay computed tomography (LMK-CT) score from the baseline
Time frame: 12 months.
Change of Health-related quality -of- life (HRQL) from the baseline (Euro-QOL-5D questionnaire)
Time frame: 12 months
Change in sense of smell using the University of Pennsylvania Smell Identification Test (UPSIT) from the baseline
Time frame: 12 months
Clinical pharmacokinetics of paclitaxel in 15 subjects
Time frame: 10 days
Change in Asthma Control Questionnaire-6 (ACQ-5) Scores from baseline for subjects with comorbid asthma
Time frame: 12 months
Nasal DCB performance evaluation in index procedures
Time frame: one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Related trials for Chronic Rhinosinusitis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coral Leticia Benítez Insaurralde, MD principal investigator
Sanatorio Americano Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Airiver Nasal Drug Coated Balloon (DCB) Catheter. in people with Chronic Rhinosinusitis, run by Airiver Medical, Inc. at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety: Freedom from major device related adverse events (MADE) post index procedure assessed by the proportion of subjects free from the primary safety event through 30 days. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.