VENASEAL SPECTRUM
Research type
Research Study
Full title
VenaSeal Spectrum: 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.
IRAS ID
275752
Contact name
Lucas Peternelli
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 11 months, 31 days
Research summary
Traditionally varicose veins are treated surgically, where the patient is under general anaesthetic. However, this is associated with the higher risks of surgery and long recovery times. A newer method of treatment is a minimally invasive approach known as Endothermal Ablation (ETA). Here an injection of local anaesthetic is administered around the vein, then a small incision or needle is inserted to access the diseased vein. Heat is then delivered into the vein via the catheter attached to either a radiofrequency generator or a laser. However, ETA still has some risks, such as skin burns due to the use of heat and pain from the administration of local anaesthetic, which in turn can lead to a longer time to recovery.
The Medtronic VenaSeal™ closure system has been developed as an alternative to the other available treatment options. This procedure uses a medical grade adhesive, or glue, delivered by catheter to ‘close’ the diseased vein. This removes the need for local anaesthetic or any heat application to vein.
This study will evaluate the patient’s experience and clinical improvement after treatment with the Medtronic VenaSeal™ system compared to Standard of Care treatments such as surgical stripping or ETA, in the treatment of varicose veins. In the VLU study, the study will also collect specific information on wound healing from subjects with an active venous leg ulcer.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0384
Date of REC Opinion
31 Jan 2020
REC opinion
Further Information Favourable Opinion