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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04280679
Other study ID # HIFU-VN-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2020
Est. completion date September 10, 2020

Study information

Verified date October 2020
Source Theraclion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device.

The original Sonovein device was tested in a clinical trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.


Description:

The Sonovein 2 system provides high intensity focused ultrasound (HIFU) abaltion of soft tissue. The energy is delievered via an extra-corporeal treatment probe, which includes an imaging system. The high energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue within the focal area. The process is then repeated in a stepwize fashion to destroy the targeted tissues. The Sonovein 2 system is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), a computer with touchscreen user interface. In addition, the Sonovein 2 system is intended to be used in conjunction with a disposable cooling and coupling system known as ePack.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 10, 2020
Est. primary completion date September 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Candidate for venous procedure involving lower limb superficial insufficiency involving reflux in the segment to be treated

2. Physical condition allowing ambulation after the procedure

3. Availability of the patient for all the follow-up visits

4. Targeted tissue reachable for treatment with the device-meaning between 5mm and 26mm below the skin surface

5. Age over 18 years of age at the time of enrollment

6. No acute venous thrombosis

7. No complete, or near complete deep vein thrombosis

8. Patient has signed a written informed consent

9. Targeted structure sonographically visible

Exclusion Criteria:

1. Patient is pregnant or nursing

2. Known allergic reaction to anesthetic to be used

3. Legally incapacitated or imprisoned patients

4. Patient's vein target not clearly visible on the ultrasound images (B mode) at the inclusion visit

5. Patient participating in another clinical trial involving an investigational drug, device or biologic

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sonovein 2
Patient are treated with the HIFU device and the pysician is doing a compressive bandage

Locations

Country Name City State
Austria Karl Landsteiner Institut für funktionelle Phlebochirurgie Melk

Sponsors (1)

Lead Sponsor Collaborator
Theraclion

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of venous reflux As measured by ultrasound 3 months
Secondary Emergent Adverse Events Measure of AEs and SAEs recorded in AE form at each visit 3 months
Secondary Measurement of the need to use tumescence anesthesia during the procedure Evaluated dichotomously present/absent 3 months
Secondary Measurement of the need to use adjunctive procedure for treating the reflux Evaluated dichotomously present/absent 3 months
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