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Freezing away pain: new hope for stubborn vein lumps

NCT ID NCT01845935

Symptom relief Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a freezing technique called cryoablation on 14 adults with painful venous malformations that had come back after standard treatments like surgery or sclerotherapy. The main goal was to check safety and see if it could ease pain and discomfort. Results focused on side effects and symptom improvement, offering a possible less-invasive option for hard-to-treat cases.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

14 people

The number who actually took part.

Start date

Apr 2013

Finished

Aug 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patient over 18 years, * Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI, * Recurrence of symptoms after initial treatment, * Symptomatic deformation :pain, tangible mass,functional discomfort * Recurrence after treatment by surgery or sclerosis * Cryotherapy considered technically feasible after discussion in multidisciplinary committee, * Localization at distance from the skin and major neurovascular structures, * Absence of contra-indication of anaesthesia, * Signed informed consent, * Coverage by French social security Exclusion Criteria: * Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve), * TP \<50% TCA\> 1.5 x control, anticoagulation * Platelets \<90000/mm3, * Progressive infection * Patient included in another clinical study, * Unable to undergo medical tests for geographical, social or psychological, * Adult under a legal guardianship or unable to consent, * Pregnancy and breastfeeding.

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Conditions

The condition(s) this trial relates to.

Pain vascular malformation venous hemangioma

As listed by the trial registrant

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

Venous vascular malformation

Contacts and locations

Locations

  • University Hospital Bordeaux, France

    Bordeaux, 33076, France