Venclose digiRF System for Chronic Venous Insufficiency

Enrolling by invitation at 6 trial locations

Overseen By Mai-Ly Wilcox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: C. R. Bard

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, BMI >35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Day 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for chronic venous insufficiency, a condition where leg veins struggle to return blood to the heart, often causing swelling and discomfort. The study uses the Venclose digiRF System to treat malfunctioning veins, focusing on the great and small saphenous veins and incompetent perforator veins. It seeks participants with significant vein problems causing symptoms like leg pain or swelling. Those diagnosed with these vein issues who haven't undergone certain treatments may qualify. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on active anticoagulant therapy (blood thinners) for conditions like Deep Vein Thrombosis.

What prior data suggests that the Venclose digiRF System is safe for treating chronic venous insufficiency?

Research shows that the Venclose digiRF System and the Venclose MAVEN System are generally well-tolerated for treating chronic venous disease. In past studies, patients used these systems to treat problematic veins, and the results were positive.

For the Venclose digiRF System, studies indicate it effectively improves conditions like chronic venous insufficiency, with participants experiencing few side effects. This suggests the treatment is safe.

The Venclose MAVEN System, which includes the MAVEN catheter, treats specific problem veins. It is designed to safely close off these veins, and research supports its safety with no major concerns reported.

Overall, these treatments appear well-tolerated, with research supporting their safe use in treating venous diseases. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Venclose digiRF System for treating chronic venous insufficiency because it offers a unique approach compared to traditional treatments like endovenous laser therapy or radiofrequency ablation. The Venclose system uses a cutting-edge digiRF generator paired with specialized catheters, which allows for more precise and controlled energy delivery to target incompetent veins such as the Great and Small Saphenous Veins and Incompetent Perforator Veins. This precision may lead to improved effectiveness and potentially fewer complications. Additionally, the advanced technology of the MAVEN and EVSRF catheters could provide enhanced treatment efficiency and patient comfort, making it a promising alternative to existing methods.

What evidence suggests that the Venclose digiRF System is effective for treating chronic venous insufficiency?

Research has shown that the Venclose digiRF System effectively treats chronic venous insufficiency. In this trial, participants may receive treatment using either the Venclose MAVEN System, which includes the digiRF generator with the MAVEN catheter, or the Venclose System with the EVSRF catheter. The Venclose MAVEN™ catheter targets specific veins that often cause chronic venous issues. Data from past treatments indicate improved vein function and symptom relief. This system compares favorably to other treatments, suggesting it effectively manages venous conditions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic venous disease, specifically in the great and small saphenous veins or incompetent perforator veins. Participants must understand the study, agree to follow-ups, have a vein diameter that meets the study's requirements, and be able to walk. Those with less severe venous issues (below CEAP class C2) cannot join.

Inclusion Criteria

My vein condition is at least at a moderate severity level.

I can walk on my own.

Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule

Exclusion Criteria

I have a known bleeding or clotting disorder.

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

I have not had, nor plan to have, major surgery around the time of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Venclose digiRF procedure for treatment of chronic venous disease

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Venclose digiRF System
• Venclose MAVEN System (digiRF generator w MAVEN catheter)
• Venclose System (digiRF generator w EVSRF catheter)

Trial Overview The Venclose MAVEN System using digiRF generator with MAVEN catheter and Venclose System using digiRF generator with EVSRF catheter are being tested on patients with chronic venous insufficiency to see how well they treat vein reflux diseases.

How Is the Trial Designed?

Group I: IPV Experimental Treatment 1 Intervention

Incompetent Perforator Veins

Group II: GSV/SSV Experimental Treatment 1 Intervention

Incompetent Great and Small Saphenous Veins

Who Is Running the Clinical Trial?

C. R. Bard

Lead Sponsor

Trials

109

Recruited

40,200+

Timothy M. Ring

C. R. Bard

Chief Executive Officer since 2003

Bachelor of Science in Industrial and Labor Relations from Cornell University

Dr. Cimler

C. R. Bard

Chief Medical Officer since 2017

Ph.D. in Pharmacology

Published Research Related to This Trial

The VenoValve, a prosthetic venous valve, was successfully implanted in 10 patients with severe chronic venous insufficiency (C5-C6), achieving a 100% technical success rate and showing promising early results in improving clinical outcomes and quality of life after 6 months.

Patients demonstrated significant improvements, including a 61% decrease in venous clinical severity scores and a 57% decrease in pain scores, indicating that the VenoValve may be an effective treatment option for those suffering from severe CVI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency. Ulloa, JH., Glickman, M.[2022]

Citations

1. veithsymposium.org veithsymposium.org/2024/abstracts/vei/828.pdf

Venclose GSC/SSV to be treated that has outward flow reflux ≥0.5 seconds immediately after release of manual distal compression with subject.

2. venclose.com venclose.com/wp-content/uploads/2024/08/BD-55448-Venclose-Maven%E2%84%A2-Catheter-Physician-Training-1.pdf

BD-55448 The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular ...

3. bd.com bd.com/en-us/products-and-solutions/products/product-families/venclose-maven-perforator-catheter

Venclose Maven™ Perforator Catheter For patients with Chronic Venous Disease (CVD), the Venclose Maven™ Perforator Catheter is used for treatment of incompetent perforator veins (IPVs) and ...

4. withpower.com withpower.com/trial/phase-venous-insufficiency-8-2022-88ff2

Venclose digiRF System for Chronic Venous Insufficiency What data supports the effectiveness of the Venclose digiRF System treatment for chronic venous insufficiency? The network meta-analysis comparing VenaSeal ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05504070?term=nct05504070&rank=1

Venclose digiRF System Post Market Study Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

6. venclose.com venclose.com/wp-content/uploads/2024/09/BD-71383-Venclose-Maven-Product-and-Disease-Informational-1.pdf

Chronic Venous Disease and Treatment Information Venclose Maven™ Perforator Catheter. Chronic Venous Disease (CVD). The Venclose Maven™ Catheter is intended for endovascular coagulation of blood vessels in ...