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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The balloon is coated with a paclitaxel drug (3.5ug/mm2).
Sanatorio Americano Hospital
Asunción, Paraguay
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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