Cryoablation of Venous Vascular Malformations

Cryoablation of Venous Vascular Malformations Located in Soft Tissues

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01845935

Acronym

CRYOMAV

Enrollment

Registered

2013-05-03

Start date

2013-04-01

Completion date

2015-08-01

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Vascular Malformation

Keywords

Cryoablation, Venous vascular malformation, MRI, safety, pain

Brief 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 recurrences are common.

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.

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.	7 days after cryoablation
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.	1 month after cryoablation
To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.	6 months after cryoablation

Secondary

Measure	Time frame
All adverse events using NCI-CTCAE	7 days, 1 month ,2 months + 6 months after cryoablation
Clinical response (decrease of pain and/or functional discomfort)	6 months after cryoablation
Imaging response (RECIST 1.1)	6 months after cryoablation
Quality of life using QLQ-C30	2 months & 6 months after cryoablation
Pain using visual analogue scale	7 days, 1 month ,2 months & 6 months after cryoablation

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrançois Cornelis, MD

University Hospital Bordeaux, France

STUDY_CHAIRAdelaide Doussau, MD