Open Label Safety Investigation of Solutio™ Tumescent Catheter

NCT07823088 | Not Yet Recruiting

• 1 other identifier: CSDPR901
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Insufficiency

Outcome Measures

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.

  28 days

Secondary Outcomes (3)

• Patient experience of pain

  28 days

• Physician feedback

  1 day

• Patient experience of pain

  28 days

Study Arms (1)

Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins

EXPERIMENTAL

Administration of tumescence from inside the vein to the surrounding tissue, via Solutio™ catheter during endothermal ablation of varicose veins.

Device: Administration of local anesthesia

Interventions

Administration of local anesthesia DEVICE

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.

Solutio™ catheter used to administrate tumescence during endothermal ablation of varicose veins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedVasc AB: lead

Study Sites (2)

Hallands sjukhus

Halmstad, 301 85, Sweden

Location

Scandinavian Venous Centre

Malmö, 21135, Sweden

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael Akesson, MD

  MedVasc AB

  STUDY DIRECTOR

Central Study Contacts

Ingegerd W Dalfelt, SRN, BSc.

CONTACT

+46708433348; ingegerd.dalfelt@gmail.com

Cathrin Johansson, BSc

CONTACT

+46708548834; cathrin.johansson@medvasc.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Safety study

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 16, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)