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

NCT ID: NCT02991352

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-21

Study Completion Date

2017-11-29

Brief Summary

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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

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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

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Vascular Malformations

Keywords

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Vascular Malformations Image Guidance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Image guided needle placement into vascular malformations based on MRI

Group Type EXPERIMENTAL

Image guided needle placement

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iris Baumgartner, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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ARTORG Center for Biomedical Engineering

Bern, , Switzerland

Site Status

Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie

Bern, , Switzerland

Site Status

Universitätsklinik für Angiologie

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016-00827

Identifier Type: OTHER

Identifier Source: secondary_id

3193

Identifier Type: -

Identifier Source: org_study_id