Status:
COMPLETED
Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU
Lead Sponsor:
Theraclion
Conditions:
Varicose Veins
Veins Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device. The original Sonovein device was tested in a clinical tr...
Detailed Description
The Sonovein 2 system provides high intensity focused ultrasound (HIFU) abaltion of soft tissue. The energy is delievered via an extra-corporeal treatment probe, which includes an imaging system. The ...
Eligibility Criteria
Inclusion
- Candidate for venous procedure involving lower limb superficial insufficiency involving reflux in the segment to be treated
- 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
- Targeted structure sonographically visible
Exclusion
- Patient is pregnant or nursing
- Known allergic reaction to anesthetic to be used
- Legally incapacitated or imprisoned patients
- Patient's vein target not clearly visible on the ultrasound images (B mode) at the inclusion visit
- Patient participating in another clinical trial involving an investigational drug, device or biologic
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04280679
Start Date
March 3 2020
End Date
September 10 2020
Last Update
October 6 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karl Landsteiner Institut für funktionelle Phlebochirurgie
Melk, Austria, 3390