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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
Full description
The study is designed with two randomized studies and one single arm study.
Two randomized studies are for CEAP 2-5 subjects:
The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):
Enrollment
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Inclusion criteria
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
Eligibility for treatment:
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
Exclusion criteria
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
Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
Patient has abnormal pulse exam or ABI <0.8
Patient has acute superficial thrombophlebitis
Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
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)
IFU contraindications:
Patient is non-ambulatory
Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
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
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
Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
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)
Primary purpose
Allocation
Interventional model
Masking
506 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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