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Venous Vascular MalformationPhase 1/2CRYOMAVNCT01845935

Cryoablation of Venous Vascular Malformations

A Phase 1/2 study testing Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles) in people with Venous Vascular Malformation, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Vascular Malformation
What is being tested?
Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteFrance
Study dates
Apr 2013to Aug 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 10Show fewer
  • Localization at distance from the skin and major neurovascular structures,
  • Absence of contra-indication of anaesthesia,
  • Signed informed consent,
  • Coverage by French social security

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital Bordeaux, France

    Bordeaux, 33076

Other trials in France

About this study

Official title: Cryoablation of Venous Vascular Malformations Located in Soft Tissues

To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.

Read the detailed description

In order to propose an additional alternative option, cryoablation has been recently tested with promising results. Therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations.

Fourteen patients will be included after discussion in multidisciplinary meeting. Patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST criteria.

Being tested
Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)
Keywords
Cryoablation, Venous vascular malformation, MRI, safety, pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)Device

    Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.

Study groups in NCT01845935
Study groupRoleWhat they receive
only one treatment groupExperimentalPatients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.
Receives: Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.

    Measured: 7 days after cryoablation

  2. To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.

    Measured: 1 month after cryoablation

  3. To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.

    Measured: 2 months after cryoablation

  4. To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.

    Measured: 6 months after cryoablation

Secondary outcomes (5)

  1. All adverse events using NCI-CTCAE

    Measured: 7 days, 1 month ,2 months + 6 months after cryoablation

  2. Clinical response (decrease of pain and/or functional discomfort)

    Measured: 6 months after cryoablation

  3. Imaging response (RECIST 1.1)

    Measured: 6 months after cryoablation

  4. Quality of life using QLQ-C30

    Measured: 2 months & 6 months after cryoablation

  5. Pain using visual analogue scale

    Measured: 7 days, 1 month ,2 months & 6 months after cryoablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01845935
Sponsor's protocol ID
CHUBX 2012/15
Other IDs
2013-A00199-36
Acronym
CRYOMAV
Status last verified
Aug 2016
First submitted
23 Apr 2013
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Cornelis F, Neuville A, Labreze C, Kind M, Bui B, Midy D, Palussiere J, Grenier N. Percutaneous cryotherapy of vascular malformation: initial experience. Cardiovasc Intervent Radiol. 2013 Jun;36(3):853-6. doi: 10.1007/s00270-012-0434-9. Epub 2012 Jun 22.

    PubMed 22722720

  • Cornelis F, Havez M, Lippa N, Al-Ammari S, Verdier D, Carteret T, Amoretti N, Gangi A, Palussiere J, Hauger O, Grenier N. Radiologically guided percutaneous cryotherapy for soft tissue tumours: A promising treatment. Diagn Interv Imaging. 2013 Apr;94(4):364-70. doi: 10.1016/j.diii.2013.02.001. Epub 2013 Mar 11.

    PubMed 23491212

  • Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50. doi: 10.1001/archopht.1997.01100160312008.

    PubMed 9298055

  • Cornelis FH, Labreze C, Pinsolle V, Le Bras Y, Castermans C, Bader C, Thiebaut R, Midy D, Grenier N. Percutaneous Image-Guided Cryoablation as Second-Line Therapy of Soft-Tissue Venous Vascular Malformations of Extremities: A Prospective Study of Safety and 6-Month Efficacy. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1358-1366. doi: 10.1007/s00270-017-1636-y. Epub 2017 Mar 30.

    PubMed 28361195

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles) in people with Venous Vascular Malformation, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale. (time frame: 7 days after cryoablation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01845935, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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