Varicose VeinsNCT04280679
Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU
A study testing Sonovein 2 in people with Varicose Veins and Veins Diseases, run by Theraclion at 1 site in Austria.
Trial 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 trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Veins Diseases, Varicose Ulcer
- What is being tested?
- Sonovein 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2020to 10 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No complete, or near complete deep vein thrombosis
- Patient has signed a written informed consent
- Targeted structure sonographically visible
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Karl Landsteiner Institut für funktionelle Phlebochirurgie
Melk, 3390
About this study
Official title: Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein 2: a Single Center Prospective Study
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 trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.
Read the 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 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 within the focal area. The process is then repeated in a stepwize fashion to destroy the targeted tissues. The Sonovein 2 system is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), a computer with touchscreen user interface. In addition, the Sonovein 2 system is intended to be used in conjunction with a disposable cooling and coupling system known as ePack.
- Conditions
- Varicose Veins, Veins Diseases, Varicose Ulcer
- Being tested
- Sonovein 2
- Keywords
- HIFU, High Intensity Focused Ultrasound
- Medical subject headings
- Varicose Veins, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonovein 2Device
Patient are treated with the HIFU device and the pysician is doing a compressive bandage
| Study group | Role | What they receive |
|---|---|---|
| Arm of patient treated by HIFU | Other | Compression bandages Receives: Device: Sonovein 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of venous reflux
As measured by ultrasound
Measured: 3 months
Secondary outcomes (3)
Emergent Adverse Events
Measure of AEs and SAEs recorded in AE form at each visit
Measured: 3 months
Measurement of the need to use tumescence anesthesia during the procedure
Evaluated dichotomously present/absent
Measured: 3 months
Measurement of the need to use adjunctive procedure for treating the reflux
Evaluated dichotomously present/absent
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start3 Mar 2020
- Primary completion9 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies 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
- Model description
- Monocentric study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfred OBERMAYER, MD, Principal investigator, Karl Landsteiner Insitut fur funktionelle Phlebochirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280679
- Sponsor's protocol ID
- HIFU-VN-002
- Status last verified
- Oct 2020
- First submitted
- 11 Feb 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein 2: a Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT04280679
- Acronym / sponsor ID
- HIFU-VN-002
- Conditions
- Varicose Veins, Veins Diseases, Varicose Ulcer
- Keywords
- HIFU, High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 21 Feb 2020 (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 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 trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.
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 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 within the focal area. The process is then repeated in a stepwize fashion to destroy the targeted tissues. The Sonovein 2 system is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (VTU), a computer with touchscreen user interface. In addition, the Sonovein 2 system is intended to be used in conjunction with a disposable cooling and coupling system known as ePack.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric study
| Arm | Type | Receives |
|---|---|---|
| Arm of patient treated by HIFU | Other | Device: Sonovein 2Compression bandages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 2Patient are treated with the HIFU device and the pysician is doing a compressive bandage | Device | Arm of patient treated by HIFU |
Primary outcome
Reduction of venous reflux
Time frame: 3 months
As measured by ultrasound
3 secondary outcomes
Emergent Adverse Events
Time frame: 3 months
Measurement of the need to use tumescence anesthesia during the procedure
Time frame: 3 months
Measurement of the need to use adjunctive procedure for treating the reflux
Time frame: 3 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 6 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Alfred OBERMAYER, MD principal investigator
Karl Landsteiner Insitut fur funktionelle Phlebochirurgie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonovein 2 in people with Varicose Veins and Veins Diseases, run by Theraclion at 1 site in Austria.
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 5 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Reduction of venous reflux (time frame: 3 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 6 Oct 2020.