Vascular MalformationsSIGVaMNCT02991352
Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
A study testing Image guided needle placement in people with Vascular Malformations, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Malformations
- What is being tested?
- Image guided needle placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 21 Mar 2017to 29 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
ARTORG Center for Biomedical Engineering
Bern, 3008
Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie
Bern, 3010
Universitätsklinik für Angiologie
Bern, 3010
About this study
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.
Read the 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.
- Conditions
- Vascular Malformations
- Being tested
- Image guided needle placement
- Keywords
- Vascular Malformations, Image Guidance
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image guided needle placementDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Image guided needle placement into vascular malformations based on MRI Receives: Device: Image guided needle placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach the target
Time from start of targeting to alcohol embolization in minutes
Measured: During the intervention (duration approx. 90 minutes on average)
Secondary outcomes (6)
Radiation time
Measured by the C-arm imaging device in seconds
Measured: During the intervention (duration approx. 90 minutes on average)
Radiation dose
Measured by the C-arm imaging device in μGym²
Measured: During the intervention (duration approx. 90 minutes on average)
Contrast agent volume
Measured by the nurses in milliliter
Measured: During the intervention (duration approx. 90 minutes on average)
Number of attempts
Defined as number of skin punctures, counted by the investigator
Measured: During the intervention (duration approx. 90 minutes on average)
Reason to change to standard approach
Asked by the investigator
Measured: During the intervention (duration approx. 90 minutes on average)
System Usability Score (SUS)
Filled out by the interventionalist
Measured: Directly after the intervention (60 minutes afterwards at the latest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start21 Mar 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Iris Baumgartner, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991352
- Sponsor's protocol ID
- 3193
- Other IDs
- 2016-00827, 2016
- Acronym
- SIGVaM
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2016
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
- ClinicalTrials.gov ID
- NCT02991352
- Acronym / sponsor ID
- SIGVaM / 3193
- Conditions
- Vascular Malformations
- Keywords
- Vascular Malformations, Image Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Image guided needle placementImage guided needle placement into vascular malformations based on MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image guided needle placementStereotactic 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) | Device | Experimental |
Primary outcome
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
6 secondary outcomes
Radiation time
Time frame: During the intervention (duration approx. 90 minutes on average)
Radiation dose
Time frame: During the intervention (duration approx. 90 minutes on average)
Contrast agent volume
Time frame: During the intervention (duration approx. 90 minutes on average)
Number of attempts
Time frame: 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)
System Usability Score (SUS)
Time frame: Directly after the intervention (60 minutes afterwards at the latest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Baumgartner, MD principal investigator
Insel Gruppe AG, University Hospital Bern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided needle placement in people with Vascular Malformations, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach the target (time frame: During the intervention (duration approx. 90 minutes on average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.