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NCT05149664 · ClinicalTrials.gov registry record · NA
A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD
A NA study of Peripheral Arterial Disease (PAD), sponsored by Vibrato Medical.
- Active
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05149664: Active NA study of Peripheral Arterial Disease (PAD), sponsored by Vibrato Medical.
NCT05149664 is a NA study of Peripheral Arterial Disease (PAD) that is active but no longer recruiting, run by Vibrato Medical. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05149664, a NA study of Peripheral Arterial Disease (PAD), is active but no longer recruiting, sponsored by Vibrato Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
(2) Mean difference between pre-treatment (baseline) and post-treatment, and at the 1-, 3-, and 6-months post-treatment follow up visits, using Clarifi Imaging System (Modulim), which uses spatial frequency domain imaging (SFDI), to measure tissue oxygen saturation (StO2) and tissue hemoglobin (Hb) in the dermal microcirculation (HbT1) and macrocirculation (HbT2) to assess lower extremity blood supply.
Conditions Studied
Interventions
- DEVICE Therapeutic ultrasound (TUS)
Study Locations (1)
California
- Vascular & Interventional Specialists of Orange County - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2023-12 |
| Phase | NA |
What the registry record for NCT05149664 still lists
NCT05149664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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.
NCT05149664 reports a single indexed study location in California.
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).
What interventions are being tested in trial NCT05149664?
The interventions under investigation include: Therapeutic ultrasound (TUS) (DEVICE).
Who is sponsoring clinical trial NCT05149664?
This trial is sponsored by Vibrato Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05149664's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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