Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs (INVOLVE)

C

Centre Hospitalier Universitaire de Besancon

Status

Unknown

Conditions

Venous Insufficiency of Leg

Treatments

Device: VBox Hybrid

Study type

Interventional

Funder types

Other

Identifiers

NCT04534244
API/2020/103

Details and patient eligibility

About

The prevalence of superficial chronic venous insufficiency (CVI) of the lower limbs is estimated at 18 million French people. The number of patients operated for varicose veins is around 300,000 per year. Post-operative complications such as venous ulcer, venous thrombosis and varicose vein rupture require a lot of medical care. Varicose veins are responsible for a decrease in quality of life and represents 1 to 2% of total health expenditure. Currently, operating techniques tend towards minimally invasive procedures in order to minimize the surgical trauma, improve patient comfort and reduce the time of postoperative work stoppages. This study aims to compare two surgical techniques for the treatment of superficial chronic venous insufficiency of the lower limbs : phlebectomy, the gold-standard technique, and endovenous steam treatment. Several studies have already been carried out on endovenous steam treatment for saphenous veins but none has been published concerning the tributary veins.The main objective of INVOLVE is to assess the quality of life of patients 1 month after surgery. Clinical improvement and economic impact will also be evaluated.

Enrollment

134 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
  • Signature of the informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
  • Affiliation to a French social security scheme or beneficiary of such a scheme
  • Patient with a reflux of the tributary veins, associated or not with a reflux of the large saphenous veins
  • Patient with a reflux of the tributary veins already treated for a reflux at the saphenous level
  • Clinical stage between C2 and C5 (from the CEAP classification). Diameter of the vein between 3 and 13 mm
  • Patient treated with one or two lower limbs
  • Patient able to understand and complete a quality of life questionnaire

Exclusion criteria

  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
  • Subject without health insurance
  • Pregnant woman
  • Subject in the period of exclusion from another study or provided for by the "national file of volunteers"
  • Patient with an absolute or relative contraindication to the treatment of his varicose veins by an endovenous technique
  • Venous insufficiency at the expense of the small saphenous vein
  • Patient with a history of venous thrombosis
  • Patient with hemostasis disorders
  • Patient with an associated severe pathology (cancer, heart failure, renal failure)
  • Patient treated with sclerotherapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

Control group
No Intervention group
Description:
Treatment of the tributary veins by phlebectomy
Experimental group
Experimental group
Description:
Endovenous steam treatment of the tributary veins
Treatment:
Device: VBox Hybrid

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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