Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03304834
Other study ID # HIFU-VV-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2017
Est. completion date August 30, 2018

Study information

Verified date November 2018
Source Theraclion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
ECHOPULSE
Patient are treated with the HIFU device and the physician 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 Measurement of flow abolition As measured by ultrasound 3 months
Secondary Emergent Adverse Events Measure of AEs and SAEs and adjunctive procedures for treating the reflux 3 months
See also
  Status Clinical Trial Phase
Withdrawn NCT02561013 - A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers N/A
Recruiting NCT05364112 - Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency N/A
Completed NCT00656383 - Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population N/A
Active, not recruiting NCT02973893 - Study of VF001-DP in Patients With Chronic Venous Leg Ulcers Phase 2
Not yet recruiting NCT02873728 - Remote Ischemic Conditioning for Treatment of Chronic Wounds N/A
Completed NCT01998932 - Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb N/A
Recruiting NCT06135246 - Laser Therapy for Venous Leg Ulcers N/A
Active, not recruiting NCT03744858 - The Role of Pyroptosis in Chronic Venous Disease
Completed NCT01449422 - Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers. Phase 4
Completed NCT00838500 - THERMES ET VEINES: Spa for Prevention of Leg Ulcers Phase 3
Completed NCT04039789 - Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care. N/A
Completed NCT04280679 - Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU N/A
Completed NCT02512159 - Skin Ulcers Treatment With an Handicraft Topical Device Phase 4
Completed NCT02896725 - Wool-derived Keratin Dressings for Venous Leg Ulcers N/A
Completed NCT04310280 - Effects of Local Insulin on Varicose Ulcers for Wound Healing Phase 3
Completed NCT02626156 - Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence Phase 2
Recruiting NCT03127904 - Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial N/A
Terminated NCT00727701 - Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development Phase 1
Withdrawn NCT00648674 - A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers Phase 4
Completed NCT00399308 - Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers Phase 1/Phase 2