Clinical Research Directory

Open Label Safety Investigation of Solutio™ Tumescent Catheter

Sponsor: MedVasc AB

Summary

The goal of this clinical investigation is to evaluate safety of the Solutio™ catheter when administering tumescent anesthesia before treatment with endothermal ablation in adults above the age of 18, who suffer from unilateral insufficiency of the great saphenous vein (GSV). Main question(s) to answer is: Safety evaluated through reported Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs). Incidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), and device deficiency (DD) throughout the investigation. All investigation participants will: * Undergo screening, including medical history, physical examination, and vein mapping with Doppler ultrasound. * Have their Great Saphenous Vein (GSV) treated using Seldinger technique under ultrasound guidance. * Receive tumescent anesthesia injected from inside the vein into the perivascular tissue at selected sites along the vein, using the investigational Solutio™ catheter under ultrasound guidance. * Undergo endothermal ablation, Endovenous Laser Ablation (EVLA), or Radiofrequency Ablation (RFA). * Be followed up for 28 days through scheduled phone calls (Day 1, Day 14 ±2) and clinic visits (Day 7 ±1, Day 28 ±2) to assess adverse events, pain, patient comfort, and undergo physical/clinical examinations and ultrasound examinations of the treated area.

Official title: A Prospective, Open Label Investigation of Safety of the Solutio™ Tumescent Catheter for Endothermal Ablation of Varicose Veins

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Locations (2)