Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using HIFU (Archimedes01)
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|ClinicalTrials.gov Identifier: NCT03304834|
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Varicose Ulcer Veins Diseases Vein, Varicose||Device: ECHOPULSE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Monocentric study|
|Masking:||None (Open Label)|
|Official Title:||Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU): A Single Center Prospective Study|
|Actual Study Start Date :||August 21, 2017|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||August 30, 2018|
Arm of patient treated by HIFU
Patient are treated with the HIFU device and the physician is doing a compressive bandage.
Other Name: Compression bandage
- Reduction of venous reflux [ Time Frame: 3 months ]as measured by ultrasound
- Measurement of flow abolition [ Time Frame: 3 months ]As measured by ultrasound
- Emergent Adverse Events [ Time Frame: 3 months ]Measure of AEs and SAEs and adjunctive procedures for treating the reflux
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304834
|Karl Landsteiner Institut für funktionelle Phlebochirurgie|
|Melk, Austria, 3390|
|Principal Investigator:||Alfred OBERMAYER, MD||Karl Landsteiner Institut für funktionelle Phlebochirurgie|