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Cryoablation of Venous Vascular Malformations (CRYOMAV)

Primary Purpose

Venous Vascular Malformation

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Vascular Malformation focused on measuring Cryoablation, Venous vascular malformation, MRI, safety, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital Bordeaux, France

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

only one treatment group

Arm Description

Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.

Outcomes

Primary Outcome Measures

To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.

Secondary Outcome Measures

All adverse events using NCI-CTCAE
Clinical response (decrease of pain and/or functional discomfort)
Imaging response (RECIST 1.1)
Quality of life using QLQ-C30
Pain using visual analogue scale

Full Information

First Posted
April 23, 2013
Last Updated
August 19, 2016
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01845935
Brief Title
Cryoablation of Venous Vascular Malformations
Acronym
CRYOMAV
Official Title
Cryoablation of Venous Vascular Malformations Located in Soft Tissues
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Vascular Malformation
Keywords
Cryoablation, Venous vascular malformation, MRI, safety, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
only one treatment group
Arm Type
Experimental
Arm Description
Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.
Intervention Type
Device
Intervention Name(s)
Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)
Intervention Description
Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.
Primary Outcome Measure Information:
Title
To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.
Time Frame
7 days after cryoablation
Title
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
Time Frame
1 month after cryoablation
Title
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
Time Frame
2 months after cryoablation
Title
To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.
Time Frame
6 months after cryoablation
Secondary Outcome Measure Information:
Title
All adverse events using NCI-CTCAE
Time Frame
7 days, 1 month ,2 months + 6 months after cryoablation
Title
Clinical response (decrease of pain and/or functional discomfort)
Time Frame
6 months after cryoablation
Title
Imaging response (RECIST 1.1)
Time Frame
6 months after cryoablation
Title
Quality of life using QLQ-C30
Time Frame
2 months & 6 months after cryoablation
Title
Pain using visual analogue scale
Time Frame
7 days, 1 month ,2 months & 6 months after cryoablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Cornelis, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adelaide Doussau, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bordeaux, France
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22722720
Citation
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.
Results Reference
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PubMed Identifier
23491212
Citation
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.
Results Reference
background
PubMed Identifier
9298055
Citation
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.
Results Reference
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Cryoablation of Venous Vascular Malformations

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