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 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by DUS
3. Eligibility for treatment:
* 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
4. Treatable refluxing segment of target vein(s) 10 cm in length or longer
5. 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
6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times
7. 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 tp 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 COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
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)
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
VenaSeal™ Closure System
CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping
Donnée non disponible
Inconnu
Endothermal Ablation (ETA)
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA
Donnée non disponible
Inconnu
Surgical Stripping
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)
Donnée non disponible
Inconnu
VenaSeal™ Closure System VLU Study
CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System
Donnée non disponible
Inconnu
VenaSeal™ Closure System
État du recrutement
unknown
CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping
Endothermal Ablation (ETA)
État du recrutement
unknown
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA
Surgical Stripping
État du recrutement
unknown
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)
VenaSeal™ Closure System VLU Study
État du recrutement
unknown
CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System
Données à jour depuis :
20 février 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
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
Source : Importé depuis le centre
The study is designed with two randomized studies and one single arm study.
Two randomized studies are for CEAP 2-5 subjects:
1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)
2. VenaSeal vs. ETA Study
The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):
1. VLU Study
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
32
centres
AZIENDA OSPEDALIERA DI PADOVA OSPENDALE SANT' ANTONIO - I PIANO DAY HOSPITAL
Padova
ITALY
Recrutement local
État du recrutement:
FERMÉ
BEDFORDSHIRE HOSPITALS NHS FOUNDATION TRUST
Bedford
UNITED KINGDOM
Recrutement local
État du recrutement:
FERMÉ
CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST - ADDENBROOKE'S HOSPITAL
Cambridge
CAMBRIDGESHIRE, UNITED KINGDOM
Recrutement local
État du recrutement:
FERMÉ
CHU DIJON BOURGOGNE HOPITAL FRANCOIS MITTERAND
Dijon
DIJON CEDEX, FRANCE
Recrutement local
État du recrutement:
FERMÉ
CLINIQUE PASTEUR
Toulouse
BP 27617, FRANCE
Recrutement local
État du recrutement:
FERMÉ
COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA (HOSPITAL CAMPUS DE LA SALUD)
Granada
SPAIN
Recrutement local
État du recrutement:
FERMÉ
COMPREHENSIVE CARDIOVASCULAR CARE GROUP
Milwaukee
WISCONSIN, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
EAST TORONTO VASCULAR CLINIC
Toronto
ONTARIO, CANADA
Recrutement local
État du recrutement:
FERMÉ
GANGNAM SEVERANCE HOSPITAL, YONSEI UNIVERSITY HEALTH SYSTEM
Seoul
SEOUL-TEUKBYEOLSI [SEOUL], KOREA, REPUBLIC OF
Recrutement local
État du recrutement:
FERMÉ
GEORGETOWN UNIVERSITY MEDICAL CENTER
Washington
DISTRICT OF COLUMBIA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
20 février 2025
Données à jour depuis :
22 fév.
Origine des données :
clinicaltrials.gov
