Trial · NCT05883462
Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
NCT05883462, Early phase 1, Active not recruiting, Airiver Medical, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH). Trials, record NCT05883462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05883462
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
- NCT number
- NCT05883462
- Status
- Active not recruiting
- Phases
- Early phase 1
- Enrollment
- 45 participants, actual
- Lead sponsor
- Airiver Medical, Inc.
- Conditions
- Chronic Rhinosinusitis
- Interventions
- Airiver Nasal Drug Coated Balloon (DCB) Catheter.
- First posted
- 2023-06-01
- Last updated
- 2025-12-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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 | 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. | 6 months | assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR. |
| Secondary | Incidence of, and time to symptom-driven reintervention | 12 months | assessed by Kaplan-Meier survival analysis of the incidence of subjects free from symptom-driven TLR |
| Secondary | Change in patient reported 22-item Sino-Nasal Outcome Test (SNOT-22) from the baseline | 12 months | Total SNOT 22 score is between 0 to 110. Higher scores indicate worse rhinosinusitis. |
| Secondary | Change in Lund-Kennedy Endoscopic Scores from the baseline | 12 months | The scores range is from 0 to 20. Higher scores indicate worse observed disease. |
| Secondary | Change in Lund-Mackay computed tomography (LMK-CT) score from the baseline | 12 months. | The score range is from 0 to 24. Higher scores indicate worse disease severity. |
| Secondary | Change of Health-related quality -of- life (HRQL) from the baseline (Euro-QOL-5D questionnaire) | 12 months | 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. |
| Secondary | Change in sense of smell using the University of Pennsylvania Smell Identification Test (UPSIT) from the baseline | 12 months | The score range is between 0-40. Higher scores indicate better smell function. |
| Secondary | Clinical pharmacokinetics of paclitaxel in 15 subjects | 10 days | Blood samples will be collected at baseline and post procedure at pre-designated time points and assessed for plasma paclitaxel concentrations. |
| Secondary | Change in Asthma Control Questionnaire-6 (ACQ-5) Scores from baseline for subjects with comorbid asthma | 12 months | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05883462
GET https://conductscience.org/api/trials/v1/NCT05883462/registered