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

NCT05100745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-06-17

No results posted yet for this study

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).

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Therapeutic Device

This device delivers ultrasound energy to the targeted area of the lower limb.

Sponsors & Collaborators

  • Vibrato Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2024-05-31
Completion
2024-12-11
FDA Device
Yes

Countries

  • United States

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 NCT05100745 on ClinicalTrials.gov