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Trial record 1 of 1 for:    NCT03304834
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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
Sponsor:
Information provided by (Responsible Party):
Theraclion

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.

Condition or disease Intervention/treatment Phase
Varicose Ulcer Veins Diseases Vein, Varicose Device: ECHOPULSE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Monocentric 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): 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: ECHOPULSE
Arm of patient treated by HIFU
Device: ECHOPULSE
Patient are treated with the HIFU device and the physician is doing a compressive bandage.
Other Name: Compression bandage




Primary Outcome Measures :
  1. Reduction of venous reflux [ Time Frame: 3 months ]
    as measured by ultrasound


Secondary Outcome Measures :
  1. Measurement of flow abolition [ Time Frame: 3 months ]
    As measured by ultrasound

  2. Emergent Adverse Events [ Time Frame: 3 months ]
    Measure of AEs and SAEs and adjunctive procedures for treating the reflux



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Austria
Karl Landsteiner Institut für funktionelle Phlebochirurgie
Melk, Austria, 3390
Sponsors and Collaborators
Theraclion
Investigators
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Principal Investigator: Alfred OBERMAYER, MD Karl Landsteiner Institut für funktionelle Phlebochirurgie

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Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT03304834     History of Changes
Other Study ID Numbers: HIFU-VV-001
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theraclion:
HIFU
High intensity focused ultrasound

Additional relevant MeSH terms:
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Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases