Cryoablation of Venous Vascular Malformations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Vascular Malformation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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only one treatment group

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No