Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Wit… (NCT05883462) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
Paraguay45 participantsStarted 2023-06-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or females, ≥18 years
✓. Signed written informed consent
✓. Recurrent, symptomatic CRS (with or without nasal polyps, with or without prior sinus surgery), have:
✓. candidates for RESS or other treatment due to recurrent symptom, and endoscopically confirmed present with unilateral or bilateral polyps, and/or unilateral or bilateral mucosal disease confirmed by nasal endoscopy and/or CT
✓. bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS
✓. with or without Aspirin-Exacerbated Respiratory Disease (AERD)
✓. Acute Exacerbation of CRS (AECRS)
✓. Subjects with comorbid asthma or COPD must be stable with no exacerbations (e.g., no emergency room visits, hospitalizations) for 6 months before the screening visit
Exclusion criteria
✕. 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
What they're measuring
1
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.
Timeframe: 30 days
2
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.
. 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
✕. 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