CRYOMAV: Cryoablation of Venous Vascular Malformations

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01845935

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Vascular Malformation	Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cryoablation of Venous Vascular Malformations Located in Soft Tissues

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Bordeaux, France	Bordeaux		France	33076

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator: François Cornelis, MD, University Hospital Bordeaux, France
Study Chair: Adelaide Doussau, MD, University Hospital Bordeaux, France