Status:
COMPLETED
Cryoablation of Venous Vascular Malformations
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Venous Vascular Malformation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 s...
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 cryot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01845935
Start Date
April 1 2013
End Date
August 1 2015
Last Update
August 22 2016
Active Locations (1)
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1
University Hospital Bordeaux, France
Bordeaux, France, 33076