Open Label Safety Investigation of Solutio™ Tumescent Catheter
10 september 2026 uppdaterad av: MedVasc AB
A Prospective, Open Label Investigation of Safety of the Solutio™ Tumescent Catheter for Endothermal Ablation of Varicose Veins
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ingegerd W Dalfelt, SRN, BSc.
- Telefonnummer: +46708433348
- E-post: ingegerd.dalfelt@gmail.com
Studera Kontakt Backup
- Namn: Cathrin Johansson, BSc
- Telefonnummer: +46708548834
- E-post: cathrin.johansson@medvasc.se
Studieorter
-
-
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Halmstad, Sverige, 301 85
- Hallands sjukhus
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Kontakt:
- Karin Ludwigs, MD
- Telefonnummer: +46 (0)35 14 77 53
- E-post: Karin.Ludwigs@regionhalland.se
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Malmö, Sverige, 21135
- Scandinavian Venous Centre
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Kontakt:
- Karin Ludwigs, MD
- Telefonnummer: +46707382447
- E-post: karin.ludwigs@svcgoteborg.se
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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.
- Subject accepts to be treated without any sedation.
- Subject is willing and able to provide written informed consent.
Exclusion Criteria:
- 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.
- Subject with GSV insufficiency in the distal 2/3 of the lower leg.
- Subject, who demands full sedation, or general anesthesia.
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins
Administration of tumescence from inside the vein to the surrounding tissue, via Solutio™ catheter during endothermal ablation of varicose veins.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety related to the procedure using the Solutio™ catheter.
Tidsram: 28 days
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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.
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28 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient experience of pain
Tidsram: 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"
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28 days
|
|
Physician feedback
Tidsram: 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.
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1 day
|
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Patient experience of pain
Tidsram: 28 days
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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".
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28 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Michael Akesson, MD, MedVasc AB
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
28 september 2026
Primärt slutförande (Beräknad)
30 december 2026
Avslutad studie (Beräknad)
28 februari 2027
Studieregistreringsdatum
Först inskickad
1 september 2026
Först inskickad som uppfyllde QC-kriterierna
10 september 2026
Första postat (Faktisk)
16 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CSDPR901
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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produkt tillverkad i och exporterad från U.S.A.
Nej
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