Soundbite Crossing System Peripheral First in Man

Status Completed

Clinical Trial Summary

This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in the lower extremity arteries without major adverse events related to SoundBite device utilization.

Clinical Trial Description

Prospective, multi-center, single-arm, two-phase clinical study. This study will be conducted in two phases.

The first phase will consist of ten (10) subjects enrolled and treated using the SoundBite Crossing System with 30 day follow-up. An analysis shall be performed after 10 subjects undergo treatment with the SoundBite Crossing System and complete 30 day follow-up. This analysis shall be utilized to provide insight into product performance and safety.

The second phase will consist of up to forty (40) subjects enrolled and treated using the SoundBite Crossing System with 30 day follow-up. An analysis will be generated on this subject cohort after 30 day follow-up is complete. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03013088
Study type	Interventional
Source	SoundBite Medical Solutions, Inc.
Contact
Status	Completed
Phase	N/A
Start date	December 2016
Completion date	September 2017

View Details

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