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

Sponsor

Theraclion (Industry)

Overall Status

Completed

CT.gov ID

NCT04280679

Collaborator

(none)

Enrollment

Location

Arm

6.3

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Veins Veins Diseases Varicose Ulcer	Device: Sonovein 2	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Monocentric studyMonocentric study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 3, 2020

Actual Primary Completion Date :

Sep 9, 2020

Actual Study Completion Date :

Sep 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction of venous reflux [3 months]
As measured by ultrasound

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Candidate for venous procedure involving lower limb superficial insufficiency involving reflux in the segment to be treated
Physical condition allowing ambulation after the procedure
Availability of the patient for all the follow-up visits
Targeted tissue reachable for treatment with the device-meaning between 5mm and 26mm below the skin surface
Age over 18 years of age at the time of enrollment
No acute venous thrombosis
No complete, or near complete deep vein thrombosis
Patient has signed a written informed consent
Targeted structure sonographically visible

Exclusion Criteria:

Patient is pregnant or nursing
Known allergic reaction to anesthetic to be used
Legally incapacitated or imprisoned patients
Patient's vein target not clearly visible on the ultrasound images (B mode) at the inclusion visit
Patient participating in another clinical trial involving an investigational drug, device or biologic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karl Landsteiner Institut für funktionelle Phlebochirurgie	Melk		Austria	3390

Sponsors and Collaborators

Theraclion

Investigators

Principal Investigator: Alfred OBERMAYER, MD, Karl Landsteiner Insitut fur funktionelle Phlebochirurgie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Theraclion

ClinicalTrials.gov Identifier:

NCT04280679

Other Study ID Numbers:

HIFU-VN-002

First Posted:

Feb 21, 2020

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Theraclion

HIFU

High Intensity Focused Ultrasound

Additional relevant MeSH terms:

Varicose Veins

Varicose Ulcer

Study Results

No Results Posted as of Oct 6, 2020