Chronic Venous InsufficiencyNCT04386785
Venclose RF Ablation System for the Treatment of IPVs
A study testing Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins in people with Chronic Venous Insufficiency, run by Venclose, Inc. at 1 site in United States.
Trial summary
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2020to 13 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is >= 18 years.
- IPVs to be treated have an outward flow duration of >= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
- IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
- Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
- Is able to ambulate.
- Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
- Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Who cannot join
- Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
- Has thrombus in the vein segment to be treated.
- Has untreated critical limb ischemia from peripheral arterial disease.
- Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
- Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
- Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
Show all 10Show fewer
- Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
- Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study.
- Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure.
- Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vein Center of East Texas at CardioStream
Tyler, Texas, 75701
About this study
Official title: Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency (RF) Thermal Ablation of Incompetent Perforator VeinsDevice
The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm: Endovascular thermal ablation in IPV | Experimental | Not described Receives: Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Measured: 3-day post-procedure
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Measured: 15-day post-procedure
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Measured: 30-day post-procedure
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Measured: Day of procedure
Effectiveness: Successful Access and Entry Into the IPV
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Measured: 3-day post ablation
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Measured: 15-day post ablation
Effectiveness: Technical Success
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Measured: 30-day post ablation
Secondary outcomes (6)
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Measured: 3-day post-procedure follow-up
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Measured: 15-day post-procedure
Acute Ablation Success
The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.
Measured: 30-day post-procedure
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Measured: 3-day post-procedure
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Measured: 15-day post-procedure
Reflux
Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.
Measured: 30-day post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start23 May 2020
- Primary completion13 Apr 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venclose, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Carr, MD, Principal investigator, Vein Center of East Texas at CardioStream
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386785
- Sponsor's protocol ID
- CL-VAV-001
- Status last verified
- May 2022
- First submitted
- 7 May 2020
- Last updated
- 27 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)
- ClinicalTrials.gov ID
- NCT04386785
- Acronym / sponsor ID
- CL-VAV-001
- Conditions
- Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Venclose, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Posted 27 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm: Endovascular thermal ablation in IPV | Experimental | Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is >= 18 years.
- IPVs to be treated have an outward flow duration of >= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
- IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
- Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
- Is able to ambulate.
Key exclusion criteria (10 listed)
- Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
- Has thrombus in the vein segment to be treated.
- Has untreated critical limb ischemia from peripheral arterial disease.
- Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
- Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
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 |
|---|---|---|
| Radiofrequency (RF) Thermal Ablation of Incompetent Perforator VeinsThe physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound. | Device | Single-arm: Endovascular thermal ablation in IPV |
Primary outcome
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Time frame: 3-day post-procedure
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Time frame: 15-day post-procedure
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Safety: AEs, SAEs, ADEs, SADEs, UADEs
Time frame: 30-day post-procedure
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Effectiveness: Technical Success
Time frame: Day of procedure
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Successful Access and Entry Into the IPV
Time frame: 3-day post ablation
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Technical Success
Time frame: 15-day post ablation
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Technical Success
Time frame: 30-day post ablation
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
6 secondary outcomes
Acute Ablation Success
Time frame: 3-day post-procedure follow-up
Acute Ablation Success
Time frame: 15-day post-procedure
Acute Ablation Success
Time frame: 30-day post-procedure
Reflux
Time frame: 3-day post-procedure
Reflux
Time frame: 15-day post-procedure
Reflux
Time frame: 30-day post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jeffrey Carr, MD principal investigator
Vein Center of East Texas at CardioStream
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins in people with Chronic Venous Insufficiency, run by Venclose, Inc. 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 7 inclusion and 10 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 27 May 2022. 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?
Yes. Results are posted in the registry (first posted 27 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety: AEs, SAEs, ADEs, SADEs, UADEs (time frame: 3-day post-procedure). The study lists 7 primary outcomes in all. 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 27 May 2022.