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

NCT ID: NCT03304834

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2018-08-30

Brief Summary

This is a single-center prospective study with a planned accrual of 35 patients with diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency (including recurrence at the thigh/groin level after previous treatment). The eligible patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will return to clinic on a separate day for the HIFU treatment. Device performance parameters will be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months, changes in veins and flow characteristics will be evaluated by ultrasound and physical exam, and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 3 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment. An interim Safety Report will be issued after the first 5 patients will arrive at the 7 days visit and will be provided to the Ethics Committee. A second report will be issued once the first 5 patients will complete the follow-up period of 30 days and will be also provided to the Ethics Committee.

Detailed Description

The Echopulse System provides High Intensity Focused Ultrasound (HIFU) ablation of soft tissue. The energy is delivered 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 stepwise fashion to destroy the targeted tissues.

The Echopulse System is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), and computer with touchscreen user interface. In addition, the Echopulse System is intended to be used in conjunction with a disposable cooling and coupling system known as EPack.

This is a single-center prospective study with a planned accrual of 35 patients with diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency (including recurrence at the thigh/groin level after previous treatment). The eligible patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will return to clinic on a separate day for the HIFU treatment. Device performance parameters will be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months, changes in veins and flow characteristics will be evaluated by ultrasound and physical exam, and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 3 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment. An interim Safety Report will be issued after the first 5 patients will arrive at the 7 days visit and will be provided to the Ethics Committee. A second report will be issued once the first 5 patients will complete the follow-up period of 30 days and will be also provided to the Ethics Committee.

Conditions

Varicose Ulcer; Veins Diseases; Vein, Varicose

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECHOPULSE

Arm of patient treated by HIFU

Group Type: EXPERIMENTAL

ECHOPULSE

Intervention Type: DEVICE

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

Interventions

ECHOPULSE

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

Intervention Type: DEVICE

Other Intervention Names

Compression bandage

Eligibility Criteria

Inclusion Criteria

• Candidate for venous procedure involving lower limb superficial insufficiency, recurrence at the thigh/groin level or perforators incompetence.
• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theraclion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred OBERMAYER, MD

Role: PRINCIPAL_INVESTIGATOR

Karl Landsteiner Institut für funktionelle Phlebochirurgie

Locations

Karl Landsteiner Institut für funktionelle Phlebochirurgie

Melk, , Austria

Countries

Austria

Other Identifiers

HIFU-VV-001

Identifier Type: -

Identifier Source: org_study_id