- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991352
Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study (SIGVaM)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bern, Switzerland, 3008
- ARTORG Center for Biomedical Engineering
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Bern, Switzerland, 3010
- Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie
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Bern, Switzerland, 3010
- Universitätsklinik für Angiologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Image guided needle placement into vascular malformations based on MRI
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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During the intervention (duration approx. 90 minutes on average)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation time
Time Frame: During the intervention (duration approx. 90 minutes on average)
|
Measured by the C-arm imaging device in seconds
|
During the intervention (duration approx. 90 minutes on average)
|
Radiation dose
Time Frame: During the intervention (duration approx. 90 minutes on average)
|
Measured by the C-arm imaging device in μGym²
|
During the intervention (duration approx. 90 minutes on average)
|
Contrast agent volume
Time Frame: During the intervention (duration approx. 90 minutes on average)
|
Measured by the nurses in milliliter
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During the intervention (duration approx. 90 minutes on average)
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Number of attempts
Time Frame: During the intervention (duration approx. 90 minutes on average)
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Defined as number of skin punctures, counted by the investigator
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During the intervention (duration approx. 90 minutes on average)
|
Reason to change to standard approach
Time Frame: During the intervention (duration approx. 90 minutes on average)
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Asked by the investigator
|
During the intervention (duration approx. 90 minutes on average)
|
System Usability Score (SUS)
Time Frame: Directly after the intervention (60 minutes afterwards at the latest)
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Filled out by the interventionalist
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Directly after the intervention (60 minutes afterwards at the latest)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Iris Baumgartner, MD, University Hospital Inselspital, Berne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3193
- 2016-00827 (Other Identifier: Kantonale Ethikkommission Bern (KEK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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