MedTrace Logo

Vacuum Assisted Sclerotherapy Performed by Catheter

NCT05581524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-05-02

No results posted yet for this study

Summary

VelexTM Venous Catheter is a venous catheter for temporary use to treat a vein isolated segment, designed for the treatment of varicose veins of lower limbs by means of chemical ablation or empty-vein sclerotherapy.

V.A.S.C. is a multicentric, prospective, open label, non-randomized PMCF study of VelexTM venous catheter used according to the indication of use within the scope of the CE mark.

VelexTM venous catheter is intended for patients with varicose veins of lower limbs. The total minimum number of patients is 24 and the maximum 36 for the two centers participating. Each center shall enroll at least 8 patients andno more than 28.

Conditions

  • Varicose Veins of Lower Limb

Interventions

DEVICE

VASC

At day 0 the patient will undergo the VASC treatment procedure with VelexTM device. VelexTM venous catheter is inserted in the introducer and pushed in the desired position under echo guidance. At 7 days, 1, 3 and 6 months after the procedure, the patients will undergo a clinical examination and an echo-color doppler assessment.

Sponsors & Collaborators

  • I-VASC S.r.l

    lead INDUSTRY

Principal Investigators

  • Mario MS Salerno · I-VASC S.r.l

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581524 on ClinicalTrials.gov