Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study (SIGVaM)
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|ClinicalTrials.gov Identifier: NCT02991352|
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vascular Malformations||Device: Image guided needle placement||Not Applicable|
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)|
|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|
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)
- 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
- Radiation time [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]Measured by the C-arm imaging device in seconds
- Radiation dose [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]Measured by the C-arm imaging device in μGym²
- Contrast agent volume [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]Measured by the nurses in milliliter
- Number of attempts [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]Defined as number of skin punctures, counted by the investigator
- Reason to change to standard approach [ Time Frame: During the intervention (duration approx. 90 minutes on average) ]Asked by the investigator
- System Usability Score (SUS) [ Time Frame: Directly after the intervention (60 minutes afterwards at the latest) ]Filled out by the interventionalist
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
|ARTORG Center for Biomedical Engineering|
|Bern, Switzerland, 3008|
|Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie|
|Bern, Switzerland, 3010|
|Universitätsklinik für Angiologie|
|Bern, Switzerland, 3010|
|Principal Investigator:||Iris Baumgartner, MD||University Hospital Inselspital, Berne|