VenaSeal™ Closure System for Venous Reflux

Phase-Based Estimates
1
Effectiveness
1
Safety
Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud), Granada, Spain
VenaSeal™ Closure System - Device
Eligibility
18+
All Sexes
Eligible conditions
Venous Reflux

Study Summary

This study is evaluating whether a new device may help treat varicose veins.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether VenaSeal™ Closure System will improve 4 primary outcomes and 28 secondary outcomes in patients with Venous Reflux. Measurement will happen over the course of Index procedure.

30 days
For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)
For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)
Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Month 60
Anatomic closure of primary target vein
Month 12
Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline
Month 60
Anatomic closure of target vein
Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline
Month 60
Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline
Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline
6 months
Anatomic closure of the primary target superficial truncal vein
Month 60
Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms
Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)
Month 60
For VLU Study: Ulcer recurrence on the target limb
Index procedure
For VLU Study: Percentage of target vein treated
Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Provider experience evaluating overall satisfaction with the procedure
Technical success of each target vein
Month 12
Adverse events (AEs) occurring in the target limb
Number and type of adjunctive treatment conducted
Month 24
Time to ulcer healing (For VLU study)
Month 24
For VLU study: Ulcer healing rate
Day 30
Time to return to normal activities
Time to return to work
Month 60
Additional adverse events
For VLU study only: Number of ulcer related healthcare resources utilized
Number of healthcare resources utilized for adverse events
Number of healthcare resources utilized for target limb venous reflux disease
Reintervention of any target vein
Time to reintervention of any target vein
Day 30
Intra-procedural and post-procedural pain
Through 60 months
For VLU Study: Ulcer-free time

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

3 Treatment Groups

Surgical Stripping
VenaSeal™ Closure System

This trial requires 806 total participants across 3 different treatment groups

This trial involves 3 different treatments. VenaSeal™ Closure System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

VenaSeal™ Closure System
Device
CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping
Surgical Stripping
Procedure
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)
Endothermal Ablation (ETA)
Device
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through 60 months for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient is ≥18 years of age
Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by DUS
VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
VLU Study: patients should be eligible for treatment with the VenaSeal™ system
Treatable refluxing segment of target vein(s) 10 cm in length or longer
Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
Patient is willing and capable of complying with specified follow-up evaluations at the specified times
Patient has an ability to understand the requirements of the study and to provide informed consent

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get venous reflux a year in the United States?

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The national venous reflux rate with clinical diagnosis is about 28.5% and without clinical diagnosis is about 41%. Approximately 25% have significant reflux. We estimate 20% are affected with clinically significant disease.

Unverified Answer

What are common treatments for venous reflux?

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Although no specific treatment for venous reflux appears to be proven effective, lifestyle modification is indicated if patients experience venous symptoms. Medication is a secondary form of treatment. Minimizing dietary fat is useful as a nonpharmacologic measure to limit the flow of gastric acids into the veins.

Unverified Answer

What are the signs of venous reflux?

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Venous reflux is a chronic, recurrent, often asymptomatic condition. Signs in symptomatic venous reflux patients frequently involve the arms, legs, torso, and sometimes head. A systematic examination, including an arm and leg examination will help to identify this condition.

Unverified Answer

Can venous reflux be cured?

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Venous reflux is caused by two major conditions: esophageal motility disorders and/or paralysis of striated muscle pump. Treatment of the former cause may reduce the incidence of reflux and improve health-related quality of life.

Unverified Answer

What causes venous reflux?

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Venous reflux may be partially caused by abnormalities in blood flow to lower limbs. When these abnormalities are corrected, the venous reflux improves or disappears.

Unverified Answer

What is venous reflux?

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Venous reflux is a condition that creates a problem for people with lower limbs venous ulcers. People with reflux are more likely to suffer venous ulcers.

Unverified Answer

Who should consider clinical trials for venous reflux?

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Clinical trials are underused in this population. Physicians may be unaware of clinical trials available for treatment of venous reflux and its correlation with CVD.

Unverified Answer

Is venaseal™ closure system safe for people?

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Venaseal™ closure system does not compromise clinical outcome in PVI in terms of success rate. It can help PVI team to be more confident, because there is less need to worry about this device.

Unverified Answer

What is the average age someone gets venous reflux?

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The average age of people with venous reflux is higher than that in the general population. Gender is the predominant factor associated with venous reflux.

Unverified Answer

What does venaseal™ closure system usually treat?

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Venous system closure devices are effective methods to decrease the recurrence of varicosity or esophageal varices in patients with varicose veins. Because of the rarity of varicose veins, venaseal closure devices are effective. Complications such as haemodialysis access are rare. Venaseal and Portacath"

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Unverified Answer

Have there been any new discoveries for treating venous reflux?

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The current treatment is not as complete as it needs to be. The development of a new treatment is possible and will probably result in better results. The most difficult problem of treating venous reflux is to stop all reflux while treating it. It is possible that with a combined new treatment it will be possible to get rid of venous reflux. However, this will not be easy.

Unverified Answer

What are the latest developments in venaseal™ closure system for therapeutic use?

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With the combination of the venaseal™ closure system and an adjustable banding sleeve, a more uniform closure of saphenofemoral junction is achieved at the site.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Venous Reflux by sharing your contact details with the study coordinator.