An Early Phase 1 interventional study of Airiver Nasal Drug Coated Balloon (DCB) Catheter. in Chronic Rhinosinusitis, sponsored by Airiver Medical, Inc.. Active, not recruiting at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Airiver Medical, Inc. · Early Phase 1, Interventional, and Treatment
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.
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.
Airiver Medical, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Up to 45 CRS subjects with recurrent symptomatic nasal obstruction eligible for Airiver Nasal DCB treatment
Recurrent, symptomatic CRS (with or without nasal polyps, with or without prior sinus surgery), have:
Or rhinorrhea (anterior/posterior)
For recurrent CRSwNP:
Exclusion Criteria:
Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Combination Product: Airiver Nasal Drug Coated Balloon (DCB) Catheter.
The balloon is coated with a paclitaxel drug (3.5ug/mm2).
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.
Time frame: 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.
Time frame: 6 months
Incidence of, and time to symptom-driven reintervention
assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: one day
Ran from Jun 2023 to primary completion in Oct 2025, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Airiver Medical, Inc.