ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 307 for:    "Parkes Weber syndrome" OR "Vascular Malformations"

Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study (SIGVaM)

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.
ClinicalTrials.gov Identifier: NCT02991352
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
Treatment of vascular malformations requires the placement of a needle within anatomically non well defined, pathological vessels, which may be as small as 1 mm, with the current state of the art relying exclusively on two dimensional fluoroscopy images for guidance. The investigators hypothesize that the combination of stereotactic image guidance with existing targeting methods will result in faster and more reproducible needle placements.

Condition or disease Intervention/treatment Phase
Vascular Malformations Device: Image guided needle placement Not Applicable

Detailed Description:

This prospective study aims to investigate the feasibility of the utilization of stereotactic image guidance technology for the needle based percutaneous treatment of peripheral vascular malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use with needle based procedures in combination with medical image data including MRI data, as required by this study.

Utilizing feedback from the stereotactic image guidance system, the interventionalist will attempt to place the needle within the malformation. The position and orientation of the needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The position of the needle relative to the desired position within the malformation will be evaluated utilizing fluoroscopy.

If necessary the position of the needle will be adjusted, this adjustment can be performed utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the physician. The final position of the needle will be confirmed on intra-operative DSA imaging and the sclerosant will be applied according to standard clinical protocols.

This single-centre pilot study will involve a total of 10 patients suffering from peripheral vascular malformations. Only non-emergency adult patients will be considered for inclusion in this trial. Inclusion will be at the discretion of the treating physician and patient. As the study is designed as a pilot trial, no comparator is considered and no blinding performed. The trial will be performed over a period of nine months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : November 29, 2017
Actual Study Completion Date : November 29, 2017


Arm Intervention/treatment
Experimental: Experimental
Image guided needle placement into vascular malformations based on MRI
Device: Image guided needle placement
Stereotactic MRI based image guidance to aid in the placement of percutaneous needles into vascular malformations using a CE marked navigation system (CAS-One IR, CAScination AG)




Primary Outcome Measures :
  1. Time to reach the target [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]
    Time from start of targeting to alcohol embolization in minutes


Secondary Outcome Measures :
  1. Radiation time [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]
    Measured by the C-arm imaging device in seconds

  2. Radiation dose [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]
    Measured by the C-arm imaging device in μGym²

  3. Contrast agent volume [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]
    Measured by the nurses in milliliter

  4. Number of attempts [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]
    Defined as number of skin punctures, counted by the investigator

  5. Reason to change to standard approach [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]
    Asked by the investigator

  6. System Usability Score (SUS) [ Time Frame: Directly after the intervention (60 minutes afterwards at the latest) ]
    Filled out by the interventionalist



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with venous or mixed venous-lymphatic malformation
  • Patients which are regular scheduled for a percutaneous treatment of a vascular malformation
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Age < 18 years

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): NCT02991352


Locations
Switzerland
ARTORG Center for Biomedical Engineering
Bern, Switzerland, 3008
Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie
Bern, Switzerland, 3010
Universitätsklinik für Angiologie
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Principal Investigator: Iris Baumgartner, MD University Hospital Inselspital, Berne

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02991352     History of Changes
Other Study ID Numbers: 3193
2016-00827 ( Other Identifier: Kantonale Ethikkommission Bern (KEK) )
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
Vascular Malformations
Image Guidance

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