Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU

Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein 2: a Single Center Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Varicose Ulcer; Veins Diseases
• Intervention / Treatment: Device: Sonovein 2

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Melk, Austria, 3390
    • Karl Landsteiner Institut für funktionelle Phlebochirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm of patient treated by HIFU; Compression bandages	Device: Sonovein 2; Patient are treated with the HIFU device and the pysician is doing a compressive bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of venous reflux	As measured by ultrasound	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergent Adverse Events	Measure of AEs and SAEs recorded in AE form at each visit	3 months
Measurement of the need to use tumescence anesthesia during the procedure	Evaluated dichotomously present/absent	3 months
Measurement of the need to use adjunctive procedure for treating the reflux	Evaluated dichotomously present/absent	3 months

Collaborators and Investigators

• Sponsor: Theraclion
• Investigators: Principal Investigator: Alfred OBERMAYER, MD, Karl Landsteiner Insitut fur funktionelle Phlebochirurgie

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: High Intensity Focused Ultrasound; HIFU
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Ulcer; Varicose Veins
• Other Study ID Numbers: HIFU-VN-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No