Fetoscopic endoluminal tracheal occlusion with Smart-TO balloon: Study protocol to evaluate effectiveness and safety of non-invasive removal

Nicolas Sananès; David Basurto; Anne-Gaël Cordier; Caroline Elie; Francesca Maria Russo; Alexandra Benachi; Jan Deprest

doi:10.1371/journal.pone.0273878

Fetoscopic endoluminal tracheal occlusion with Smart-TO balloon: Study protocol to evaluate effectiveness and safety of non-invasive removal

PLoS One. 2023 Mar 13;18(3):e0273878. doi: 10.1371/journal.pone.0273878. eCollection 2023.

Authors

Nicolas Sananès^{1

2}, David Basurto³, Anne-Gaël Cordier⁴, Caroline Elie⁵, Francesca Maria Russo^{3

6}, Alexandra Benachi⁴, Jan Deprest^{3

6

7}

Affiliations

¹ Department of Maternal Fetal Medicine, Strasbourg University Hospital, Strasbourg, France.
² INSERM 1121 'Biomaterials and Bioengineering', Strasbourg University, Strasbourg, France.
³ MyFetUZ Fetal Research Center, Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
⁴ Department of Maternal fetal Medicine, Antoine-Béclère Hospital - Paris-Saclay University, Clamart, France.
⁵ Clinical Research Unit/Clinical Investigation Center, Necker-Enfants Malades Hospital, Paris, France.
⁶ Clinical Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.
⁷ Institute for Women's Health, University College London, London, United Kingdom.

Abstract

Introduction: One of the drawbacks of fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia is the need for a second invasive intervention to reestablish airway patency. The "Smart-TO" (Strasbourg University-BSMTI, France) is a new balloon for FETO, which spontaneously deflates when positioned near a strong magnetic field, e.g., generated by a magnetic resonance image (MRI) scanner. Translational experiments have demonstrated its efficacy and safety. We will now use the Smart-TO balloon for the first time in humans. Our main objective is to evaluate the effectiveness of prenatal deflation of the balloon by the magnetic field generated by an MRI scanner.

Material and methods: These studies were first in human (patients) trials conducted in the fetal medicine units of Antoine-Béclère Hospital, France, and UZ Leuven, Belgium. Conceived in parallel, protocols were amended by the local Ethics Committees, resulting in some minor differences. These trials were single-arm interventional feasibility studies. Twenty (France) and 25 (Belgium) participants will have FETO with the Smart-TO balloon. Balloon deflation will be scheduled at 34 weeks or earlier if clinically required. The primary endpoint is the successful deflation of the Smart-TO balloon after exposure to the magnetic field of an MRI. The secondary objective is to report on the safety of the balloon. The percentage of fetuses in whom the balloon is deflated after exposure will be calculated with its 95% confidence interval. Safety will be evaluated by reporting the nature, number, and percentage of serious unexpected or adverse reactions.

Conclusion: These first in human (patients) trials may provide the first evidence of the potential to reverse the occlusion by Smart-TO and free the airways non-invasively, as well a safety data.

Copyright: © 2023 Sananès et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Airway Obstruction* / etiology
Balloon Occlusion* / adverse effects
Female
Fetoscopy / adverse effects
Fetoscopy / methods
Fetus
Hernias, Diaphragmatic, Congenital* / diagnostic imaging
Hernias, Diaphragmatic, Congenital* / surgery
Humans
Perinatology
Pregnancy
Trachea / diagnostic imaging
Trachea / surgery

Grants and funding

DB is funded by the Erasmus + Programme of the European Union (Framework Agreement number: 2013-0040). This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. JD is funded by the Great Ormond Street Hospital Charity Fund. In Paris, the present clinical protocol is funded by a grant from Assistance Publique – Hôpitaux de Paris (CRC19). In Leuven, the study is funded by the Klinisch Onderzoeks- en Ontwikkelingsfonds of the UZ Leuven (S65423). The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.