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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05888740
Other study ID # 022-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Vibrato Medical, Inc.
Contact Bisrat Woldemichael
Phone 213-921-0588
Email bisrat@vibratomedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Age = 65 2. Diagnosis of PAD. 3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator. Exclusion Criteria: 1. Prior stenting in posterior tibial artery. 2. Re-vascularization procedure within 30 days prior to enrollment in the study. 3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). 4. History or diagnosis of severe chronic venous insufficiency. 5. Acute limb ischemia within 30 days prior to treatment. 6. History or diagnosis of deep venous thrombosis below the knee in treatment leg. 7. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data. 8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period. stenting in posterior tibial artery.

Study Design


Intervention

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

Locations

Country Name City State
United States Vascular & Interventional Specialists of Orange County Orange California

Sponsors (1)

Lead Sponsor Collaborator
Vibrato Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 201 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean acute flow rate difference during TUS treatment sessions Quantify perfusion rate Through study completion, an average of 1 month
Primary Tissue oxygen saturation (StO2) Assess oxygenation Through study completion, an average of 1 month
Primary Ankle Brachial Index Ankle brachial indices to assess the difference in blood pressure in the upper arm and lower limbs Through study completion, an average of 1 month
Secondary Safety Endpoint Device and procedure related adverse events Through study completion, an average of 1 month
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