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

NCT02991352 | Completed

• 2 other identifiers: 31932016-00827
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Vascular Malformations

Keywords

Vascular Malformations; Image Guidance

Outcome Measures

Primary Outcomes (1)

• Time to reach the target

  Time from start of targeting to alcohol embolization in minutes

  During the intervention (duration approx. 90 minutes on average)

Secondary Outcomes (6)

• Radiation time

  During the intervention (duration approx. 90 minutes on average)

• Radiation dose

  During the intervention (duration approx. 90 minutes on average)

• Contrast agent volume

  During the intervention (duration approx. 90 minutes on average)

• Number of attempts

  During the intervention (duration approx. 90 minutes on average)

• Reason to change to standard approach

  During the intervention (duration approx. 90 minutes on average)

Study Arms (1)

Experimental

EXPERIMENTAL

Image guided needle placement into vascular malformations based on MRI

Device: Image guided needle placement

Interventions

Image guided needle placement 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)

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (3)

ARTORG Center for Biomedical Engineering

Bern, 3008, Switzerland

Location

Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie

Bern, 3010, Switzerland

Location

Universitätsklinik für Angiologie

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Vascular Malformations

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Iris Baumgartner, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 13, 2016
• Study Start: March 21, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)