Varicose Veins of Lower Limb Clinical Trial
Official title:
Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
Verified date | October 2018 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.
Status | Completed |
Enrollment | 132 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - clinical classification of venous disease C2-C4 - ultrasound-verified reflux in the GSV - mean GSV diameter in the thigh between 5 and 12 millimetres - informed consent. Exclusion Criteria: - body mass index (BMI) of over 40 - peripheral arterial disease - lymphoedema - pregnancy - allergy to either the sclerosant or lidocaine - severe general illness - malignancy - previous deep venous thrombosis - previous varicose vein intervention in the same leg - coagulation disorders |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Helsinki University Central Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occlusion rate | Occlusion rate of the great saphenous vein | One year after the treatment | |
Primary | Freedom from reflux | The absence of reflux in the treated great saphenous vein | One year after the treatment | |
Primary | Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | One year after the treatment | |
Primary | Occlusion rate | Occlusion rate of the great saphenous vein | three years after the treatment | |
Primary | Freedom from reflux | The absence of reflux in the treated great saphenous vein | three years after the treatment | |
Primary | Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | three years after the treatment | |
Primary | Occlusion rate | Occlusion rate of the great saphenous vein | five years after the treatment | |
Primary | Freedom from reflux | The absence of reflux in the treated great saphenous vein | five years after the treatment | |
Primary | Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | five years after the treatment | |
Secondary | Peroperative and immediate postoperative pain | Perceived pain using Visual Analogue Scale (Range 0-10; 0=no pain; 2=Mild pain, 4=Nagging, uncomfortable pain; 6= Miserable pain; 8=Horrible pain; 10=worst possible, unbearable pain) | During the procedure, immediately after, and at one week after the treatment | |
Secondary | Sick leave | Number of sick leave days necessary after the treatment | During the immediate postoperative period up to one month | |
Secondary | Pain medication | The amount and type of pain medication received during and after the treatment | During the immediate postoperative period up to one month | |
Secondary | 30-day occlusion rate | The occlusion rate of the treated great saphenous vein | 30 days after the treatment | |
Secondary | Complications | All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment | Up to five years after the treatment |
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