Cryoablation of Venous Vascular Malformations (CRYOMAV)

University Hospital of Bordeaux

Status and phase: Completed; Phase 2; Phase 1

Conditions: Venous Vascular Malformation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01845935

CHUBX 2012/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

only one treatment group

Experimental group

Description:

Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.

Treatment:

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