NCT05100745

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Vibrato Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Therapeutic Device	This device delivers ultrasound energy to the targeted area of the lower limb.

Timeline

• Start date: 2023-03-13
• Primary completion: 2024-05-31
• Completion: 2024-12-11
• First posted: 2021-10-29
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study