Trial record 2 of 137 for:    "capillary malformation-arteriovenous malformation syndrome" OR "Vascular Malformations"

Cryoablation of Venous Vascular Malformations (CRYOMAV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01845935
First received: April 23, 2013
Last updated: November 18, 2013
Last verified: November 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. [ Time Frame: 1 month after cryoablation ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. [ Time Frame: 2 months after cryoablation ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale. [ Time Frame: 6 months after cryoablation ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 14
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845935

Contacts
Contact: François Cornelis, MD 0033 5 56 79 55 99 francois.cornelis@chu-bordeaux.fr
Contact: Nicolas Grenier, MD PhD 0033 5 56 79 55 99 Nicolas.grenier@chu-bordeaux.fr

Locations
France
University Hospital Bordeaux, France Recruiting
Bordeaux, France, 33076
Contact: François Cornelis, MD    0033 5 56 79 55 99    francois.cornelis@chu-bordeaux.fr   
Contact: Nicolas Grenier, MD PhD    0033 5 56 79 55 99    Nicolas.grenier@chu-bordeaux.fr   
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

Publications:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01845935     History of Changes
Other Study ID Numbers: CHUBX 2012/15
Study First Received: April 23, 2013
Last Updated: November 18, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Cryoablation
Venous vascular malformation
MRI
safety
pain

Additional relevant MeSH terms:
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014