Cryoablation of Venous Vascular Malformations

Phase 1

Completed

• Conditions: Venous Vascular Malformation
• Interventions: Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)

• Registration Number: NCT01845935
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
only one treatment group	Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)	Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Imaging response (RECIST 1.1)	6 months after cryoablation
Quality of life using QLQ-C30	2 months & 6 months after cryoablation
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
Pain using visual analogue scale	7 days, 1 month ,2 months & 6 months after cryoablation

Trial Locations

Locations (1)

University Hospital Bordeaux, France; 🇫🇷 Bordeaux, France