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Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

  • Study HIC#:2000028013
  • Last Updated:07/15/2021

VenaSeal Spectrum Study is a Post-market, Randomized Study for the treatment of early and advanced stage venous disease. The treatments offered in this study are:

1. VenaSeal™ Closure System (Study product)

Uses a medical grade adhesive to close the veins.

2. Endothermal ablation (Control Arm)

Uses heat to close the veins.

All the products that will be used in this study are approved by FDA and commercially available. None of the treatments are experimental in this study.


What is Venous Disease?

This is a medical condition which affects the blood circulation in your leg. Venous reflux disease develops when one-way valves valves stop working properly and allow blood to flow backward and pool in the lower leg veins, leading to varicose veins.

Varicose veins can cause symptoms such as heaviness, aching or throbbing pain in the lower legs, cramps, restless leg syndrome, itchiness, fatigue, swelling and tenderness along the vein.

Varicose veins can also sometimes cause wounds, or venous leg ulcers (VLU) which can cause additional pain and tenderness.

  • Age18 years and older
  • GenderBoth
  • Start Date01/20/2021
  • End Date11/29/2022

Eligibility Criteria

Eligibility Criteria

 

Inclusion Criteria:

1. Patient is ≥18 years of age

2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP category 2 (symptomatic) or CEAP category 3, 4a, 4b, 5, 6 based on the American Venous Forum CEAP classification (2004), appropriate for treatment, as confirmed by DUS

3. Eligibility for treatment:

4. VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA

5. VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping

6. VLU Study: patients should be eligible for treatment with the VenaSeal™ system

7. Treatable refluxing segment of target vein(s) 10 cm in length or longer

8. Patient has a target vein diameter of ≥3 mm throughout the intended treatment segment of the target vein as measured by DUS while patient is standing

9. Patient is willing and capable of complying with specified follow-up evaluations at the specified times

10. Patient has an ability to understand the requirements of the study and to provide informed consent

 

Exclusion Criteria:

1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity

2. Patient has known deep vein obstruction in the target limb, as identified by the site’s standard of care

3. Patient has abnormal pulse exam or ABI <0.8

4. Patient has acute superficial thrombophlebitis

5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up to 30 days pre-procedure and through 3 months post-procedure

6. Patient has any co-morbid conditions, which in the investigator’s opinion may interfere with the patient’s compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)

7. IFU contraindications:

• VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product’s IFU contraindication(s)

• VenaSeal vs. Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)

• VLU Study: Patient has VenaSeal™ system IFU contraindication(s)

 8. Patient is non-ambulatory

 9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure*

10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures

11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study

12. Patient has documented or suspected (by a clinician) COVID-19 infection currently or within the past 6 months.

13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory

14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Note: CEAP 6 VLU patients are excluded at sites not identified as VLU Study sites.

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