Varicosis
Conditions
Keywords
GSV, insufficiency, ClariVein device, safety, efficacy, QOL
Brief summary
More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.
Interventions
DEVICEClariVein
Using the ClariVein device, the GSV will be occluded.
Sponsors
St. Antonius Hospital
Rijnstate Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Insufficiency of the GSV * Ultrasound criteria for endovenous treatment have been met: * Diameter GSV between 3-12 mm * No thrombus present at the GSV part to be treated * Signed informed consent * Patient willing to present at follow-up visits * Age \> 18 jaar
Exclusion criteria
* Patient is unable to give informed consent * Patient unable to present at all follow-up visits * Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation * Pregnancy and breast feeding * Known allergy/ contra indication for sclerotherapy * Previous ipsilateral surgical treatment of varicose veins * Deep venous vein thrombosis in medical history * Anticoagulant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion rate | 30 days, 1, 2, and 5 years | The percentage of GSV occluded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease related quality of life | 30 days, 1, 2, and 5 years | Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points. |
| Pain score during procedure | peri-procedural | The pain will be scored during procedure using the VAS score. |
| 2-weeks post-procedure pain score | two weeks | The pain will be scored daily for two weeks after the procedure using the VAS score. |
| Health status | 30 days, 1, 2, and 5 years | Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points. The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. |
| procedural complications | during procedure | all complications related to the procedure will be evaluated at the mentioned time points. |
| post-procedural complications | 1 year | all complications related to the procedure will be evaluated at the mentioned time points. |
| recovery time | two weeks | The time (in days) after the procedure until patients were able to restart daily activity/daily work |
Countries
Netherlands
Outcome results
None listed