Clinical trial NCT05926830: Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study
Official title: Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study (VEINRESET)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: Varicose Vein
HIFU
Theraclion
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.


Eligibility criteria: Inclusion Criteria:

* Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
* CEAP-clinical classification ≥ 2
* Physical condition allowing ambulation after the procedure.
* Agree to comply with the Clinical investigation plan and follow-up schedule of the study
* Targeted tissue reachable for treatment with the device.
* Age over 22 years at the time of enrollment.
* No acute venous thrombosis.
* No complete or near complete deep vein post-thrombotic disease.
* Patient has signed and understood the written informed consent.

Exclusion Criteria:

* Patient is pregnant
* 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 or device.
* Ankle-brachial index \<7 (ABI)
* Undergoing active anticoagulant therapy within the last 6 months
* Diameter of the treated anatomical segment below ≤ 2mm \& above \> 20mm
* Patients where HIFU cannot be delivered to tissues where macro calcifications induce a significant shadow in the ultrasonic image
* Patients where EPack must be put in contact with an ulcer
* Patients with significant thick scars on the skin over the segment to be treated
* Security distance respected in regards of :

  * nerves \& bones
  * the surrounding vessels
* Patient who may not be considered as good candidates for treatment by the investigator outside the explicit exclusion criteria above listed

Primary outcomes:
measure: Vein Occlusion Rate
timeFrame: 12 months
Secondary outcomes:
measure: Complications
timeFrame: 12 months
measure: Reflux-free Rate
timeFrame: 12 months
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 12 months
measure: Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
timeFrame: 12 months
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Melk
country: Austria
facility: Praxis für Phlebologie
city: Říčany
country: Czechia
facility: Phlebomedica s.r.o
Study officials:
References: