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Cryoablation of Venous Vascular Malformations (CRYOMAV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845935
First Posted: May 3, 2013
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
  Purpose
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 Intervention Phase
Venous Vascular Malformation Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoablation of Venous Vascular Malformations Located in Soft Tissues

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale. [ Time Frame: 7 days after cryoablation ]
  • To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. [ Time Frame: 1 month after cryoablation ]
  • To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. [ Time Frame: 2 months after cryoablation ]
  • To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale. [ Time Frame: 6 months after cryoablation ]

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

Enrollment: 14
Study Start Date: April 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845935


Locations
France
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
  More Information
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