Venous Insufficiency
Conditions
Brief 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.
Interventions
DEVICEAdministration of local anesthesia
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.
Sponsors
MedVasc AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Safety study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female \>18 years old. 2. 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. 3. Subject is scheduled for an EVLA or RFA procedure for a unilateral insufficiency of the GSV. 4. Subject accepts to be treated with endothermal ablation as a standalone method. 5. Subject accepts to be treated without any sedation. 6. Subject is willing and able to provide written informed consent.
Exclusion criteria
1. Considered as being of high risk due to comorbidity in the opinion of the investigator. 2. Subject with known and confirmed coagulation defects. 3. Subject on anticoagulant treatment. 4. Subject who simultaneously needs to be treated with other supplemental techniques such as e.g., foam sclerotherapy, ligation, and phlebectomy. 5. Subject with GSV insufficiency in the distal 2/3 of the lower leg. 6. Subject, who demands full sedation, or general anesthesia. 7. Subject with known allergy to any of the tumescent and/or anesthetizing agents that will be used (per local standard practice) during the endothermal ablation procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety related to the procedure using the Solutio™ catheter. | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient experience of pain | 28 days | 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" |
| Physician feedback | 1 day | 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. |
Countries
Sweden
Contacts
CONTACTIngegerd W Dalfelt, SRN, BSc.
CONTACTCathrin Johansson, BSc
STUDY_DIRECTORMichael Akesson, MD
MedVasc AB
Outcome results
None listed