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This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.
The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUS Therapy | Experimental | These subjects will undergo treatments with the Vibrato Sleeve TUS device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VibratoSleeve Therapeutic Ultrasound Device | Device | The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Acute Flow Rate Difference During TUS Treatment Sessions | Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment. | Baseline to end of treatment, an average of 1 month |
| Tissue Oxygen Saturation (StO2) | Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment. | Through study completion, an average of 1 month |
| Ankle Brachial Index (ABI) | ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease. | Baseline to end of treatment, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device and Procedure-related Adverse Events | Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study. | Through study completion, an average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
stenting in posterior tibial artery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular & Interventional Specialists of Orange County | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26062950 | Result | Nazer B, Ghahghaie F, Kashima R, Khokhlova T, Perez C, Crum L, Matula T, Hata A. Therapeutic Ultrasound Promotes Reperfusion and Angiogenesis in a Rat Model of Peripheral Arterial Disease. Circ J. 2015;79(9):2043-9. doi: 10.1253/circj.CJ-15-0366. Epub 2015 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TUS Therapy | These subjects will undergo treatments with the Vibrato Sleeve TUS device. VibratoSleeve Therapeutic Ultrasound Device: The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2022 | Jun 12, 2025 |
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Prospective, single arm, open-label, feasibility acute phase study
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TUS Therapy | These subjects will undergo treatments with the Vibrato Sleeve TUS device. VibratoSleeve Therapeutic Ultrasound Device: The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Acute Flow Rate Difference During TUS Treatment Sessions | Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment. | Posted | Mean | Standard Deviation | Percent change (%) | Baseline to end of treatment, an average of 1 month |
|
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| Primary | Tissue Oxygen Saturation (StO2) | Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment. | Posted | Mean | Standard Deviation | StO2% | Through study completion, an average of 1 month |
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| Primary | Ankle Brachial Index (ABI) | ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease. | Posted | Mean | Standard Deviation | Index (Ratio) | Baseline to end of treatment, an average of 1 month |
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| Secondary | Incidence of Device and Procedure-related Adverse Events | Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study. | Posted | Number | Events | Through study completion, an average of 1 month |
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Safety surveillance and reporting starts when subject receives therapy with the VibratoSleeve until the end of the final treatment visit. All treatment visits were completed within an average of 1 month per patient.
Although unlikely due to the nature of the device, the following adverse events were reported for each subject through the final treatment visit:
All device-related adverse events and events for which the relationship to the VibratoSleeve is unknown
All SAEs Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported. Planned hospitalization for a pre-existing condition is not considered a serious adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TUS Therapy | These subjects will undergo treatments with the Vibrato Sleeve TUS device. VibratoSleeve Therapeutic Ultrasound Device: The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf | 0 | 12 | 0 | 12 | 0 | 12 |
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Institution and Investigator shall have the right to publish data obtained from the Study provided that the Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for written approval, for which approval shall not be unreasonably denied. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Affairs | Vibrato Medical | 2139215088 | bisrat@vibratomedical.com |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
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