Chronic Venous Insufficiency Clinical Trial
— VEINRESETOfficial 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)
Verified date | June 2024 |
Source | Theraclion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | September 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Praxis für Phlebologie | Melk | |
Czechia | Phlebomedica s.r.o | Rícany | |
United States | Englewood Health | Englewood | New Jersey |
United States | Northwell Health | Lake Success | New York |
Lead Sponsor | Collaborator |
---|---|
Theraclion |
United States, Austria, Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound) | 12 months | |
Secondary | Complications | Number of limbs presenting complications and side effects resulting from the GSV intervention | 12 months | |
Secondary | Reflux-free Rate | Percentage of limbs without reflux in the treated vein (as measured by Duplex ultrasound) | 12 months | |
Secondary | Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 12 months | |
Secondary | Clinical-Etiology-Anatomy-Pathophysiology (CEAP) | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 12 months |
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