Cryoablation of Venous Vascular Malformations

Venous Vascular Malformation Clinical Trial

— CRYOMAV  

Official title:

Cryoablation of Venous Vascular Malformations Located in Soft Tissues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845935
• Other study ID #: CHUBX 2012/15
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 23, 2013
• Last updated: August 19, 2016
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Malformations
• Venous Vascular Malformation

Intervention

Device:
• Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)
Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.

Locations

Country	Name	City	State
France	University Hospital Bordeaux, France	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. Review. — View Citation

Cornelis F, Neuville A, Labrèze C, Kind M, Bui B, Midy D, Palussière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.		7 days after cryoablation	Yes
Primary	To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.		1 month after cryoablation	Yes
Primary	To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.		2 months after cryoablation	Yes
Primary	To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.		6 months after cryoablation	Yes
Secondary	All adverse events using NCI-CTCAE		7 days, 1 month ,2 months + 6 months after cryoablation	Yes
Secondary	Clinical response (decrease of pain and/or functional discomfort)		6 months after cryoablation	Yes
Secondary	Imaging response (RECIST 1.1)		6 months after cryoablation	Yes
Secondary	Quality of life using QLQ-C30		2 months & 6 months after cryoablation	Yes
Secondary	Pain using visual analogue scale		7 days, 1 month ,2 months & 6 months after cryoablation	Yes