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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
The Solutio™ catheter presents a technique that allows for tumescent anesthesia injections to be administered at selected sites along the vein, from inside the vein to the surrounding tissue. The purpose of the Solutio™ catheter is to prevent the pain associated with multiple injections, through sensitive skin layers along the inner side of the leg, administered prior to ablation.
Hallands sjukhus
Halmstad, Sweden
Scandinavian Venous Centre
Malmö, Sweden
Safety related to the procedure using the Solutio™ catheter.
Safety evaluated by recording the number and type of adverse device effects (ADEs) and serious adverse device effects (SADEs) related to the procedure using the Solutio™ catheter.
Time frame: 28 days
Patient experience of pain
The patient will rate their experience of pain at follow up visits at the clinic and via phone contacts. A Visual Analogue Scale (VAS) measures pain intensity. The scale consists of a 100 mm line, with two end points representing 0 = "no pain" and 100 = "worst pain imaginable". The patient will be asked to make a mark across the line according to the maximum experienced pain to indicate their pain at given timepoints. At phone contacts the patient is asked a standard question to rate their pain with a number from 0 to 10, a Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable"
Time frame: 28 days
Physician feedback
After the end of the procedure, the physician is asked to provide their feedback, assessment about 10 different aspects during the procedure. They will answer with a 4-grade scale (1 is excellent, 2 is good, 3 is fair, 4 is impossible /inadequate). Acceptable score is ≤3 for each question.
Time frame: 1 day
Patient experience of pain
At phone contacts the patient is asked a standardized question to rate their pain with a number from 0 to 10, a Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable".
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.