{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T04:02:25Z","timestamp":1792555345807,"version":"4.5.0"},"reference-count":15,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,13]],"date-time":"2023-03-13T00:00:00Z","timestamp":1678665600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010790","name":"Erasmus+","doi-asserted-by":"publisher","award":["2013-0040"],"award-info":[{"award-number":["2013-0040"]}],"id":[{"id":"10.13039\/501100010790","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001279","name":"Great Ormond Street Hospital Charity","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001279","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002738","name":"Assistance Publique - H\u00f4pitaux de Paris","doi-asserted-by":"publisher","award":["CRC19"],"award-info":[{"award-number":["CRC19"]}],"id":[{"id":"10.13039\/501100002738","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010648","name":"Universitaire Ziekenhuizen Leuven, KU Leuven","doi-asserted-by":"publisher","award":["S65423"],"award-info":[{"award-number":["S65423"]}],"id":[{"id":"10.13039\/501100010648","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Introduction<\/jats:title>\n<jats:p>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 \u201cSmart-TO\u201d (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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Material and methods<\/jats:title>\n<jats:p>These studies were first in human (patients) trials conducted in the fetal medicine units of Antoine\u2013B\u00e9cl\u00e8re 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.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0273878","type":"journal-article","created":{"date-parts":[[2023,3,13]],"date-time":"2023-03-13T17:28:25Z","timestamp":1678728505000},"page":"e0273878","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":22,"title":["Fetoscopic endoluminal tracheal occlusion with Smart-TO balloon: Study protocol to evaluate effectiveness and safety of non-invasive removal"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0461-8428","authenticated-orcid":true,"given":"Nicolas","family":"Sanan\u00e8s","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2022-9027","authenticated-orcid":true,"given":"David","family":"Basurto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Ga\u00ebl","family":"Cordier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Elie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca Maria","family":"Russo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Benachi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Deprest","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,3,13]]},"reference":[{"issue":"3","key":"pone.0273878.ref001","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1053\/j.sempedsurg.2017.04.011","article-title":"Abnormal lung development in congenital diaphragmatic hernia","volume":"26","author":"D. Ameis","year":"2017","journal-title":"Semin Pediatr Surg"},{"issue":"2","key":"pone.0273878.ref002","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1056\/NEJMoa2026983","article-title":"Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia","volume":"385","author":"J.A. Deprest","year":"2021","journal-title":"N Engl J Med"},{"issue":"2","key":"pone.0273878.ref003","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1056\/NEJMoa2027030","article-title":"Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia","volume":"385","author":"J.A. Deprest","year":"2021","journal-title":"N Engl J Med"},{"issue":"3","key":"pone.0273878.ref004","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1002\/uog.23115","article-title":"Fetal endoscopic tracheal occlusion reverses the natural history of right-sided congenital diaphragmatic hernia: European multicenter experience","volume":"57","author":"F.M. Russo","year":"2021","journal-title":"Ultrasound Obstet Gynecol"},{"key":"pone.0273878.ref005","article-title":"The randomized TOTAL-trials on fetal surgery for congenital diaphragmatic hernia: re-analysis using pooled data","author":"B. Van Calster","year":"2021","journal-title":"Am J Obstet Gynecol"},{"issue":"4","key":"pone.0273878.ref006","doi-asserted-by":"crossref","first-page":"297","DOI":"10.1055\/s-0036-1587331","article-title":"Procedure-Related Complications and Survival Following Fetoscopic Endotracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia: Systematic Review and Meta-Analysis in the FETO Era","volume":"27","author":"E. Araujo","year":"2017","journal-title":"Eur J Pediatr Surg"},{"issue":"1","key":"pone.0273878.ref007","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1016\/j.jpedsurg.2010.10.008","article-title":"Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia","volume":"46","author":"J. 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Vollset","year":"1993","journal-title":"Stat Med"},{"issue":"1","key":"pone.0273878.ref014","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1186\/s10397-018-1041-9","article-title":"Fetoscopic endoluminal tracheal occlusion and reestablishment of fetal airways for congenital diaphragmatic hernia","volume":"15","author":"L. Van der Veeken","year":"2018","journal-title":"Gynecol Surg"},{"issue":"1","key":"pone.0273878.ref015","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1002\/uog.23135","article-title":"Safety and efficacy of smart tracheal occlusion device in diaphragmatic hernia lamb model","volume":"57","author":"D. 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