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Catheter delivers numbing medicine from inside the vein to spare patients injection pain

NCT ID NCT07823088

Symptom relief Sponsor: MedVasc AB Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing a new device called the Solutio™ catheter to see if it can safely deliver numbing medicine (tumescent anesthesia) from inside the great saphenous vein before endothermal ablation, a common treatment for varicose veins. The trial enrolls 30 adults with venous insufficiency who are scheduled for laser or radiofrequency ablation. Participants receive the numbing medicine through the catheter, then undergo ablation, and are followed for 28 days to check for side effects and measure pain. The main goal is to assess safety, with pain relief as a secondary focus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
The Solutio™ tumescent catheter, a device that injects numbing medicine from inside the vein into surrounding tissue before endothermal ablation.
What this could lead to
If it works, this catheter could offer a less painful way to numb the leg before varicose vein ablation, possibly reducing the need for multiple needle sticks through sensitive skin.
What could go wrong
This is a small, early safety study with 30 participants and no control group, so it cannot prove the device works better than standard care. The catheter may cause bleeding, infection, or nerve irritation, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hallands sjukhus

    Halmstad, 301 85, Sweden

  • Scandinavian Venous Centre

    Malmö, 21135, Sweden

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