Venclose digiRF System Post Market Study

March 16, 2026 updated by: C. R. Bard

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Thornton, Colorado, United States, 80602
        • ClinRe
    • Hawaii
      • Kailua, Hawaii, United States, 96740
        • Pacific Vascular Institute
    • Michigan
      • Roseville, Michigan, United States, 48066
        • Eastlake Cardiovascular
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health
    • Texas
      • Tyler, Texas, United States, 75702
        • CHRISTUS Health
    • Virginia
      • Colonial Heights, Virginia, United States, 23834
        • ClinRe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is age 18 and older
  2. Subject has CEAP clinical class C2 and higher.
  3. Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
  4. 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.
  5. For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
  6. For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
  7. For IPV only: IPVs must be located under a healed or active ulcer.
  8. Is able to ambulate.
  9. Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
  10. Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.

Exclusion Criteria:

  1. Has had previous treatment for venous insufficiency in the same target vein.
  2. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
  3. Has thrombus in the vein segment to be treated.
  4. Has untreated critical limb ischemia from peripheral arterial disease.
  5. 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.
  6. Subjects with known bleeding and/or clotting disorders.
  7. Has ABI <0.8
  8. Subject is pregnant or breastfeeding
  9. For GSV/SSV only: has a BMI >35.
  10. For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
  11. Unable to ambulate, or restrictive ambulation.
  12. Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
  13. Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
  14. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GSV/SSV
Incompetent Great and Small Saphenous Veins
Device: 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.
Experimental: IPV
Incompetent Perforator Veins
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occlusion
Time Frame: 1-Month
Cumulative Incidence of Occlusion
1-Month
DVT & PE Serious Adverse Events
Time Frame: 1-Month
Cumulative Incidence of Device and Procedural Related Deep venous thrombosis & Pulmonary Embolism Serious Adverse Events
1-Month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Distribution of rVCSS score
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
Distribution of CIVIQ-20 score
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
Distribution of CEAP clinical class
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
Distribution of VAS Pain score
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
Proportion of Recanalization of treated veins
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
Mean Duration of Procedure
Day 1 Index Procedure visit
Endovenous Heat Induced Thrombosis (2-4)
Time Frame: 1-Month (+7 days) visit
Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4
1-Month (+7 days) visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BDPI-21-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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