Cryoablation of Venous Vascular Malformations (CRYOMAV)

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.

Study Overview

• Status: Completed
• Conditions: Venous Vascular Malformation
• Intervention / Treatment: Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • University Hospital Bordeaux, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: only one treatment group; Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.	Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles); Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.

What is the study measuring?

Primary Outcome Measures

Outcome 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 delayed complications using NCI-CTCAE toxicity scale.	2 months after cryoablation
To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.	6 months after cryoablation

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: François Cornelis, MD, University Hospital Bordeaux, France; Study Chair: Adelaide Doussau, MD, University Hospital Bordeaux, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimated): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: MRI; pain; safety; Cryoablation; Venous vascular malformation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Equipment and Supplies; Needles
• Other Study ID Numbers: CHUBX 2012/15; 2013-A00199-36 (Other Identifier: ANSM)