Open Label Safety Investigation of Solutio™ Tumescent Catheter
ConditionVenous Insufficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedVasc AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female >18 years old.
Subject diagnosed with venous insufficiency in the Great Saphenous Vein from the groin to the proximal 1/3 of the lower leg and with a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 2 or higher.
Subject is scheduled for an EVLA or RFA procedure for a unilateral insufficiency of the GSV.
Subject accepts to be treated with endothermal ablation as a standalone method.
Disqualifiers
Considered as being of high risk due to comorbidity in the opinion of the investigator.
Subject with known and confirmed coagulation defects.
Subject on anticoagulant treatment.
Subject who simultaneously needs to be treated with other supplemental techniques such as e.g., foam sclerotherapy, ligation, and phlebectomy.
Trial design
Design model
Single group
Treatments tested in this trial
Administration of local anesthesia
DeviceThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veinsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
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 day3
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 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: