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

NCT04534244 | Withdrawn

• 1 other identifier: API/2020/103
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

• Comparison of the quality of life relative to the health of patients after endovenous steam treatment versus phlebectomy of the tributary veins

  Questionnaire : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) : target dimension " VEINES-QoL symptom summary score ". High values indicate better outcomes.

  one month after the intervention

Secondary Outcomes (3)

• Comparison of the evolution of the quality of life relating to health of patients after endovenous steam treatment versus phlebectomy of the tributary veins

  8-15 days, 3, 6, 9 and 12 months after the intervention

• Comparison of occlusion of the tributary veins after endovenous steam treatment versus phlebectomy of the tributary veins

  8-15 days and one year after the intervention

• Evaluation of the period of resumption of activity for people in activity after endovenous steam treatment versus phlebectomy of the tributary veins

  up to 1 year

Other Outcomes (4)

• Comparison of secondary complications after endovenous steam treatment versus phlebectomy of the tributary veins

  8-15 days, 1, 6 and 12 months after the intervention

• Comparison of postoperative pain after endovenous steam treatment versus phlebectomy of the tributary veins

  Daily for the first 8 days after surgery

• Comparison of the clinical improvement felt by the patient

  1, 6 months and one year after the intervention

Study Arms (2)

Control group

NO INTERVENTION

Treatment of the tributary veins by phlebectomy

Experimental group

EXPERIMENTAL

Endovenous steam treatment of the tributary veins

Device: VBox Hybrid

Interventions

VBox Hybrid DEVICE

Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: September 1, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2020-05