Hull Endovenous thermoAblative Trial (HEAT)
Research type
Research Study
Full title
A Prospective Single Blinded Randomised Control Trial Comparing the 1470mm Wavelength Laser and Radiofrequency (ClosureFast™) Endovenous Ablative Techniques For the Treatment of Symptomatic Varicose Veins
IRAS ID
113934
Contact name
Ian Chetter
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals
Research summary
Around 1 in 3 people suffer with varicose veins and they have a significant impact on sufferer’s quality of life. The symptoms are progressive and include pain, itching, irritation, skin changes and thickening along with ulceration. The overall cost of treating problems associated with venous insufficiency is approximately 1-3% of the entire NHS budget and so is a significant burden to both sufferers and health services. \nThe traditional treatment was to perform an operation with a general anaesthetic and an incision in the groin or the back of the knee. The leaking vein was tied off and removed by stripping. Overall this surgery is an effective treatment and improves patient’s quality of life. However it is a relatively invasive procedure and it can take a while for the patient to recover back to normal activity. \n\nNewer less invasive techniques of treatment have been developed which challenge the use of surgery. Two procedures include Endovenous Laser Ablation (EVLA)and the ClosureFAST™ System (CF). Both procedures rely on heating the inside of the vein to seal the vein and lead to vein scarring. EVLA utilies a laser beam to rapidly heat the vein. The ClosureFAST system works in a similar way to a kettle element or bulb to heat the inside of the vein to lower temperatures than laser. Both techniques are performed with patient awake under local anaesthetic and can result in less pain than surgery with a rapid return to normal activities. \n\nThis study will compare the outcomes of EVLA and CF treatments. The key outcome assessed will be pain during tha procedure and for the week after, alongwith the time to return to normal activities and the technical success in treating the diseased vein.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
13/NW/0201
Date of REC Opinion
10 Jun 2013
REC opinion
Further Information Favourable Opinion