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ACTIVE NOT RECRUITING NA

A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD

NCT05149664 · View on ClinicalTrials.gov ↗

Study Summary

All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). The most effective treatment that is comfortable to a subject will be prescribed for the remaining treatment sessions. Treatment time will be 90 minutes per session, one session per day. Thirty treatment sessions will be performed over a 45-day period. Subjects will appear for on-site follow-up visits at 1-, 3-, and 6-months following subject's last (30th) treatment session.

Interventions

  • DEVICE Therapeutic ultrasound (TUS)

Study Locations (1)

California

  • Vascular & Interventional Specialists of Orange County — Orange

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-01-14
Est. Completion 2023-12
Phase NA

Sponsor

Vibrato Medical

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05149664

The ClinicalTrials.gov registry entry for NCT05149664 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vibrato Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Peripheral Arterial Disease (PAD) appearing as the primary indexed condition, and to 1 intervention — of which Therapeutic ultrasound (TUS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05149664 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05149664 about?

NCT05149664 is a clinical study titled "A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD". All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). The most effect...

What is the current status of trial NCT05149664?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2022-01-14. Estimated completion is 2023-12.

What conditions does trial NCT05149664 study?

This clinical trial studies the following conditions: Peripheral Arterial Disease (PAD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05149664?

The interventions under investigation include: Therapeutic ultrasound (TUS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05149664?

This trial is sponsored by Vibrato Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05149664 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial