Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)

NCT05883462 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: RESTORE-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Rhinosinusitis

Keywords

recurrent, CRS with nasal polyps, CRS without nasal polyps

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (9)

• Incidence of, and time to symptom-driven reintervention

  12 months

• Change in patient reported 22-item Sino-Nasal Outcome Test (SNOT-22) from the baseline

  12 months

• Change in Lund-Kennedy Endoscopic Scores from the baseline

  12 months

• Change in Lund-Mackay computed tomography (LMK-CT) score from the baseline

  12 months.

• Change of Health-related quality -of- life (HRQL) from the baseline (Euro-QOL-5D questionnaire)

  12 months

Study Arms (1)

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).

Combination Product: Airiver Nasal Drug Coated Balloon (DCB) Catheter.

Interventions

Airiver Nasal Drug Coated Balloon (DCB) Catheter. COMBINATION_PRODUCT

The balloon is coated with a paclitaxel drug (3.5ug/mm2).

Single arm treated by Airiver Nasal DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, ≥18 years
• Signed written informed consent
• Recurrent, symptomatic CRS (with or without nasal polyps, with or without prior sinus surgery), have:
• Moderate or severe nasal congestion/blockage/obstruction
• AND decreased or loss of smell (hyposmia or anosmia),
• Or rhinorrhea (anterior/posterior)
• For recurrent CRSwNP:
• 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)
• For recurrent CRSsNP: refractory to optimal medical treatment and/or previous surgery with positive CT scan of the sinuses mucosal thickening and obstruction or positive nasal endoscopic finding (purulence or edema)
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Airiver Medical, Inc.: lead

Study Sites (1)

Sanatorio Americano Hospital

Asunción, Paraguay

Location

MeSH Terms

Conditions

Recurrence

Interventions

Catheters

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Coral Leticia Benítez Insaurralde, MD

  Sanatorio Americano Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 1, 2023
• Study Start: June 7, 2023
• Primary Completion: October 21, 2025
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

PA (1)