Venclose digiRF System for Chronic Venous Insufficiency

Recruiting at 2 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

203 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Venclose digiRF System treatment for chronic venous insufficiency?

The network meta-analysis comparing VenaSeal with other treatments for chronic venous insufficiency found that radiofrequency ablation (RFA), a similar technique to the Venclose digiRF System, was effective in achieving complete closure of treated veins and improving quality of life. This suggests that the Venclose digiRF System, which also uses radiofrequency technology, may be effective for treating chronic venous insufficiency. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Failure of microvenous valves in small superficial veins is a key to the skin changes of venous insufficiency. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Network meta-analysis to compare VenaSeal with other superficial venous therapies for chronic venous insufficiency. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Percutaneous venous valve designs for treatment of deep venous insufficiency. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. [2022]