Great Saphenous Vein InsufficiencyNCT05193643
Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)
A study testing Sonovein Treatment in people with Great Saphenous Vein Insufficiency, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Great Saphenous Vein 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 31 Jan 2023
- 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 - meaning between 5mm and 24mm below the skin surface.
- Age over 22 years at the time of enrollment.
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- 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)
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- Undergoing active anticoagulant therapy within the last 6 months
- Diameter of the treated anatomical segment below ≤ 2mm
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study
This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment.
Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV
- Conditions
- Great Saphenous Vein Insufficiency
- Being tested
- Sonovein Treatment
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 within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues.
| 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.
Technical Feasibility
Technical feasibility of the procedure in terms of the procedure technical success rate
Measured: 3 months
Secondary outcomes (1)
Ablation of venous reflux
- Ablation of venous reflux (as measured by Duplex ultrasound)
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 posted18 Jan 2022
- Study start23 Mar 2022
- Primary completion8 Oct 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Great Saphenous Vein 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193643
- Sponsor's protocol ID
- E-22-881
- Status last verified
- Jul 2022
- First submitted
- 3 Jan 2022
- Last updated
- 19 Apr 2023
- Results posted
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT05193643
- Acronym / sponsor ID
- E-22-881
- Conditions
- Great Saphenous Vein Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 18 Jan 2022 (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. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment.
Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV
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 - meaning between 5mm and 24mm below the skin surface.
Key exclusion criteria (9 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 within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues. | Device | Sonovein Treatment |
Primary outcome
Technical Feasibility
Time frame: 3 months
Technical feasibility of the procedure in terms of the procedure technical success rate
1 secondary outcome
Ablation of venous 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 19 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Treatment in people with Great Saphenous Vein Insufficiency, run by Englewood Hospital and Medical Center at 1 site in United States.
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 9 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 Apr 2023. 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 United States. 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?
Technical Feasibility (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 19 Apr 2023.