Chronic Venous InsufficiencyVEINRESETNCT05926830
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
A study testing Sonovein Treatment in people with Chronic Venous Insufficiency, run by Theraclion at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Sonovein Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 12 Oct 2023to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- No acute venous thrombosis.
- No complete or near complete deep vein post-thrombotic disease.
- Patient has signed and understood the written informed consent.
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Englewood Health
Englewood, New Jersey, 07631
Northwell Health
Lake Success, New York, 11042
About this 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)
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.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Sonovein Treatment
- Keywords
- Varicose Vein, HIFU, Theraclion
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonovein TreatmentDevice
The Sonovein 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. The process is then repeated in a stepwise fashion.
| Study group | Role | What they receive |
|---|---|---|
| Sonovein Treatment | Experimental | Not described Receives: Device: Sonovein Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)
Measured: 12 months
Secondary outcomes (4)
Complications
Number of limbs presenting complications and side effects resulting from the GSV intervention
Measured: 12 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein (as measured by Duplex ultrasound)
Measured: 12 months
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 Oct 2023
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926830
- Sponsor's protocol ID
- HIFU-VN-FDA-VEINRESET 01
- Acronym
- VEINRESET
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05926830
- Acronym / sponsor ID
- VEINRESET / HIFU-VN-FDA-VEINRESET 01
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Varicose Vein, HIFU, Theraclion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonovein Treatment | Experimental | Device: Sonovein Treatment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonovein TreatmentThe Sonovein 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. The process is then repeated in a stepwise fashion. | Device | Sonovein Treatment |
Primary outcome
Vein Occlusion Rate
Time frame: 12 months
Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)
4 secondary outcomes
Complications
Time frame: 12 months
Reflux-free Rate
Time frame: 12 months
Venous Clinical Severity Score (VCSS)
Time frame: 12 months
Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Venous Insufficiency
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonovein Treatment in people with Chronic Venous Insufficiency, run by Theraclion at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Austria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein Occlusion Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.