Status:
COMPLETED
Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using HIFU
Lead Sponsor:
Theraclion
Conditions:
Varicose Ulcer
Veins Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 hi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03304834
Start Date
August 21 2017
End Date
August 30 2018
Last Update
November 29 2018
Active Locations (1)
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1
Karl Landsteiner Institut für funktionelle Phlebochirurgie
Melk, Austria, 3390