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Original research
Overcoming roadblocks in clinical innovation via high fidelity simulation: use of a phantom simulator to achieve FDA and IRB approval of a clinical trial of fetal embolization of vein of Galen malformations
  1. Darren B Orbach1,
  2. Louise E Wilkins-Haug2,
  3. Carol B Benson3,
  4. Shivani D Rangwala4,5,
  5. Christopher Pak6,
  6. Mona Saffarzadeh6,
  7. Peter Weinstock7
  1. 1Department of Neurointerventional Radiology, Boston Children's Hospital, Boston, Massachusetts, USA
  2. 2Division of Maternal Fetal Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
  3. 3Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts, USA
  4. 4Department of Neurological Surgery, Boston Children's Hospital, Boston, Massachusetts, USA
  5. 5Department of Neurological Surgery, University of Southern California, Los Angeles, California, USA
  6. 6Boston Children’s Hospital Simulator Program (SIMPeds), Boston Children's Hospital, Boston, Massachusetts, USA
  7. 7Department of Anesthesia, BCH Simulator Program, Boston Children's Hospital, Boston, Massachusetts, USA
  1. Correspondence to Dr Darren B Orbach, Department of Neurointerventional Radiology, Boston Children's Hospital, Boston, MA 02115, USA; darren.orbach{at}childrens.harvard.edu

Abstract

Background Vein of Galen malformation (VOGM) is a rare, life-threatening vascular malformation in neonates and is treated with embolization. However, even at the most experienced centers, patients face high mortality and morbidity. In utero treatment options have been limited by lack of animal models or simulations.

Objective To create a novel ultrasound phantom simulator for a preclinical feasibility study of in utero fetal intervention for VOGM.

Methods Novel phantoms were designed and built in two configurations of spherical and windsock shape from cryogel material to mimic the salient vasculature of the fetal VOGM, based on real-patient fetal MR imaging dimensions. Critical anatomy was realistically mimicked within this model and transtorcular ultrasound-guided coil deployment was simulated. Each phantom model was assessed before and after treatment to evaluate coil mass deposition within the target.

Results The two phantoms underwent pretreatment T2-weighted MR imaging assessment, ultrasound-guided embolization, post-treatment MR and fluoroscopic imaging, and visual inspection of the sliced phantoms for target embolization verification. Postoperative MR scans confirmed realistic compact deposition of the coil masses within the central cavity. Phantom embolization results were submitted as part of the institutional review board and US Food and Drug Administration investigative device exemption approval for a first-in-humans clinical trial of fetal intervention for VOGM.

Conclusions A phantom simulator for fetal intervention of VOGM produces lifelike results during trial interventions, removing obstacles to feasibility and safety evaluations, typically precluded by non-availability of appropriate animal models. The study provides a proof of concept for potentially wider applications of medical simulation to enable novel procedural advancements in neurointerventions.

  • Vascular Malformation
  • Malformation
  • Intervention
  • Angiography

Data availability statement

No data are available. N/A.

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Data availability statement

No data are available. N/A.

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Footnotes

  • Contributors DBO: substantial conception/design of work, analysis/interpretation of the data for work, drafting/revision of the manuscript, final approval of the version published and agrees to be accountable for all aspects of the work as the guarantor. LEW-H, CBB, PW: substantial conception/design of work, analysis/interpretation of the data for work, drafting/revision of the manuscript, and final approval of the version published. SDR: drafting/revision of the manuscript, and final approval of the version published. CP: substantial conception/design of work, analysis/interpretation of the data for work, and final approval of the version published. MS: substantial conception/design of work, analysis/interpretation of the data for work, and final approval of the version published.

  • Funding This study was funded by the Sage Schermerhorn Chair for Image-Guided Therapy of the Boston Children’s Hospital Department of Radiology.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.