Pilot clinical trial of an asymmetrical balloon in the treatment of epistaxis in adult patients

Abstract

Objective: To assess safety and efficacy of an asymmetrical balloon in the treatment of epistaxis in adult patients (≥18 years) managed in an emergency setting. Methodology: Pilot, open label, monocenter, prospective, interventional non comparative study in adult patients. The patients were hospitalized for 48h, timepoint at which the device was removed. Primary endpoints were the assessment of bleeding arrest and pain score evaluated on a Visual Analogic Scale. Secondary endpoints were the nature and number of adverse events reported and patient quality of life evaluated with the RhinoQoL questionnaire. Results: Ten patients were included, and nine were treated. In Intent to Treat (ITT), bleeding was stopped upon positioning in 9/10 patients. Efficacy was maintained in 8/10 patients during treatment. Pain was moderate at insertion, inflation and during treatment and mild upon and post-removal. Minor bleeding recurrence occurred in two patients during the post-treatment period. The reported adverse events considered device-related were consistent with the ones observed with other intranasal devices. The mean and median RhinoQoL impact scores tend to decrease upon the different control visits. Conclusion: This pilot study provides promising preliminary safety and efficacy data for CAVI-TTM in the management of epistaxis in an emergency setting.