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

Primary Purpose

Varicose Veins, Veins Diseases, Varicose Ulcer

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Sonovein 2

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring HIFU, High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Karl Landsteiner Institut für funktionelle Phlebochirurgie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm of patient treated by HIFU

Arm Description

Compression bandages

Outcomes

Primary Outcome Measures

Reduction of venous reflux

As measured by ultrasound

Secondary Outcome Measures

Emergent Adverse Events

Measure of AEs and SAEs recorded in AE form at each visit

Measurement of the need to use tumescence anesthesia during the procedure

Evaluated dichotomously present/absent

Measurement of the need to use adjunctive procedure for treating the reflux

Evaluated dichotomously present/absent

Full Information

NCT ID

NCT04280679

First Posted

February 11, 2020

Last Updated

October 5, 2020

Sponsor

Theraclion

1. Study Identification

Unique Protocol Identification Number

NCT04280679

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

March 3, 2020 (Actual)

Primary Completion Date

September 9, 2020 (Actual)

Study Completion Date

September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theraclion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicose Veins, Veins Diseases, Varicose Ulcer

Keywords

HIFU, High Intensity Focused Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Monocentric study

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm of patient treated by HIFU

Arm Type

Other

Arm Description

Compression bandages

Intervention Type

Device

Intervention Name(s)

Sonovein 2

Intervention Description

Patient are treated with the HIFU device and the pysician is doing a compressive bandage

Primary Outcome Measure Information:

Title

Reduction of venous reflux

Description

As measured by ultrasound

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Emergent Adverse Events

Description

Measure of AEs and SAEs recorded in AE form at each visit

Time Frame

3 months

Title

Measurement of the need to use tumescence anesthesia during the procedure

Description

Evaluated dichotomously present/absent

Time Frame

3 months

Title

Measurement of the need to use adjunctive procedure for treating the reflux

Description

Evaluated dichotomously present/absent

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfred OBERMAYER, MD

Organizational Affiliation

Karl Landsteiner Insitut fur funktionelle Phlebochirurgie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karl Landsteiner Institut für funktionelle Phlebochirurgie

City

Melk

ZIP/Postal Code

3390

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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