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

NCT05883462 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Airiver Nasal Drug Coated Balloon (DCB) Catheter.

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

Sponsors & Collaborators

  • Airiver Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Coral Leticia Benítez Insaurralde, MD · Sanatorio Americano Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2025-10-21
Completion
2029-12-30

Countries

  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883462 on ClinicalTrials.gov