Open Label Safety Investigation of Solutio™ Tumescent Catheter
10. september 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ingegerd W Dalfelt, SRN, BSc.
- Telefonnummer: +46708433348
- E-post: ingegerd.dalfelt@gmail.com
Studer Kontakt Backup
- Navn: Cathrin Johansson, BSc
- Telefonnummer: +46708548834
- E-post: cathrin.johansson@medvasc.se
Studiesteder
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-
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Halmstad, Sverige, 301 85
- Hallands sjukhus
-
Ta kontakt med:
- 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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Ta kontakt med:
- Karin Ludwigs, MD
- Telefonnummer: +46707382447
- E-post: karin.ludwigs@svcgoteborg.se
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Safety related to the procedure using the Solutio™ catheter.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient experience of pain
Tidsramme: 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
|
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Physician feedback
Tidsramme: 1 day
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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
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Michael Akesson, MD, MedVasc AB
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
28. september 2026
Primær fullføring (Antatt)
30. desember 2026
Studiet fullført (Antatt)
28. februar 2027
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
10. september 2026
Først lagt ut (Faktiske)
16. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSDPR901
Plan for individuelle deltakerdata (IPD)
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