Venous RefluxNCT05504070
Venclose digiRF System Post Market Study
A study testing Venclose System (digiRF generator w EVSRF catheter) and Venclose MAVEN System (digiRF generator w MAVEN catheter) in people with Venous Reflux and Chronic Venous Insufficiency, run by C. R. Bard at 7 sites in United States.
Trial summary
A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Reflux, Chronic Venous Insufficiency
- What is being tested?
- Venclose System (digiRF generator w EVSRF catheter) and Venclose MAVEN System (digiRF generator w MAVEN catheter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject is age 18 and older
- Subject has CEAP clinical class C2 and higher.
- Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
- GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
- For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
- For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
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- For IPV only: IPVs must be located under a healed or active ulcer.
- 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 had previous treatment for venous insufficiency in the same target vein.
- 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 acute 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.
- Subjects with known bleeding and/or clotting disorders.
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- Has ABI <0.8
- Subject is pregnant or breastfeeding
- For GSV/SSV only: has a BMI >35.
- For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
- Unable to ambulate, or restrictive ambulation.
- Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
- 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 subject's well-being and/or confound the results or the soundness of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Atrium Health
Charlotte, North Carolina, 28204
ClinRe
Colonial Heights, Virginia, 23834
Englewood Hospital
Englewood, New Jersey, 07631
Pacific Vascular Institute
Kailua, Hawaii, 96740
Eastlake Cardiovascular
Roseville, Michigan, 48066
ClinRe
Thornton, Colorado, 80602
Christus Health
Tyler, Texas, 75702
About this study
Official title: Venclose digiRF System: A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins
A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
- Conditions
- Venous Reflux, Chronic Venous Insufficiency
- Being tested
- Venclose System (digiRF generator w EVSRF catheter), Venclose MAVEN System (digiRF generator w MAVEN catheter)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venclose System (digiRF generator w EVSRF catheter)Device
The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
Venclose MAVEN System (digiRF generator w MAVEN catheter)Device
The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.
| Study group | Role | What they receive |
|---|---|---|
| GSV/SSV | Experimental | Incompetent Great and Small Saphenous Veins Receives: Device: Venclose System (digiRF generator w EVSRF catheter) |
| IPV | Experimental | Incompetent Perforator Veins Receives: Device: Venclose MAVEN System (digiRF generator w MAVEN catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion
Cumulative Incidence of Occlusion
Measured: 1-Month
DVT & PE Serious Adverse Events
Cumulative Incidence of Device and Procedural Related Deep venous thrombosis \& Pulmonary Embolism Serious Adverse Events
Measured: 1-Month
Secondary outcomes (7)
revised Venous Clinical Severity Score (rVCSS)
Distribution of rVCSS score
Measured: Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20)
Distribution of CIVIQ-20 score
Measured: Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits
Clinical Etiological Anatomical Pathophysiological (CEAP)
Distribution of CEAP clinical class
Measured: Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
Visual Analog Scale for Pain (VAS)
Distribution of VAS Pain score
Measured: Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits
Recanalization
Proportion of Recanalization of treated veins
Measured: 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits
Duration of Procedure
Mean Duration of Procedure
Measured: Day 1 Index Procedure visit
Endovenous Heat Induced Thrombosis (2-4)
Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4
Measured: 1-Month (+7 days) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start8 Sep 2023
- Primary completion17 Jul 2025
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous RefluxStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504070
- Sponsor's protocol ID
- BDPI-21-006
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2022
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venclose digiRF System: A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins
- ClinicalTrials.gov ID
- NCT05504070
- Acronym / sponsor ID
- BDPI-21-006
- Conditions
- Venous Reflux, Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Aug 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.
A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSV/SSV | Experimental | Device: Venclose System (digiRF generator w EVSRF catheter)Incompetent Great and Small Saphenous Veins |
| IPV | Experimental | Device: Venclose MAVEN System (digiRF generator w MAVEN catheter)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 (10 listed)
- Subject is age 18 and older
- Subject has CEAP clinical class C2 and higher.
- Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
- GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
- For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
Key exclusion criteria (14 listed)
- Has had previous treatment for venous insufficiency in the same target vein.
- 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 acute 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.
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 |
|---|---|---|
| Venclose System (digiRF generator w EVSRF catheter)The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux. | Device | GSV/SSV |
| Venclose MAVEN System (digiRF generator w MAVEN catheter)The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux. | Device | IPV |
Primary outcome
Occlusion
Time frame: 1-Month
Cumulative Incidence of Occlusion
DVT & PE Serious Adverse Events
Time frame: 1-Month
Cumulative Incidence of Device and Procedural Related Deep venous thrombosis \& Pulmonary Embolism Serious Adverse Events
7 secondary outcomes
revised Venous Clinical Severity Score (rVCSS)
Time frame: Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20)
Time frame: Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits
Clinical Etiological Anatomical Pathophysiological (CEAP)
Time frame: Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits
Visual Analog Scale for Pain (VAS)
Time frame: Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits
Recanalization
Time frame: 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits
Duration of Procedure
Time frame: Day 1 Index Procedure visit
Endovenous Heat Induced Thrombosis (2-4)
Time frame: 1-Month (+7 days) visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venclose System (digiRF generator w EVSRF catheter) and Venclose MAVEN System (digiRF generator w MAVEN catheter) in people with Venous Reflux and Chronic Venous Insufficiency, run by C. R. Bard at 7 sites 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Occlusion (time frame: 1-Month). The study lists 2 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 18 Mar 2026.