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A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD — Concerto  

Peripheral Arterial Disease Clinical Trial

Official title:
A Non-significant Risk Clinical Study to Assess Changes in Perfusion Resulting From Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Peripheral Arterial Disease (PAD)

Clinical Trial Summary

The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).

Clinical Trial Description

Subjects will be randomized to a test or control group and will receive an active or sham Vibrato Sleeve respectively. Those randomized to the control arm will undergo therapy sessions with a sham Vibrato Sleeve device and two months of follow-up. Upon completion of the 2-month follow-up visit, subjects will be informed of their randomization assignment. Subjects in the sham arm will be allowed to crossover to a treatment regimen that uses an active Vibrato Sleeve device and will follow the same visit schedule as the active test group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05100745
Study type Interventional
Source Vibrato Medical, Inc.
Contact
Status Recruiting
Phase N/A
Start date March 13, 2023
Completion date December 2024
View Details
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