Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-02 @ 12:36 AM
Study NCT ID:
NCT03431792
Status:
UNKNOWN
Last Update Posted:
2018-02-13
First Post:
2018-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FETO With Long Tail Balloon for a Treatment of Severe CDH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065630', 'term': 'Hernias, Diaphragmatic, Congenital'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Treatment of fetuses with severe CDH with an observed / expected total fetal lung volume ratio (o/e TFLV) ratio \\< 25% or with o/e TFLV ratio \\< 35% combined with herniation of the liver in thorax using the intrauterine fetoscopic tracheal occlusion (FETO) with the long tail latex balloon of 2.5 ml.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neonatal survival', 'timeFrame': '1 year', 'description': 'survival rate'}], 'secondaryOutcomes': [{'measure': 'pulmonary hypoplasia', 'timeFrame': '1 year', 'description': 'clinical presence of pulmonary hypoplasia (yes - Grade /no)'}, {'measure': 'Diaphragmatic Hernia operation', 'timeFrame': '1 year', 'description': 'Patch (yes/no)'}, {'measure': 'necrotizing enterocolitis', 'timeFrame': '1 year', 'description': 'yes / no'}, {'measure': 'neurodevelopmental impairment', 'timeFrame': '1 year', 'description': '(yes, - Grade /no)'}, {'measure': 'APGAR', 'timeFrame': 'during the first 10 min after the delivery', 'description': 'APGAR (1st/5th/10th min)'}, {'measure': 'umbilical artery pH', 'timeFrame': 'during 10 min after the delivery', 'description': 'pH measument in the umbilical artery'}, {'measure': 'weight', 'timeFrame': '24hour', 'description': 'weight in (g)'}, {'measure': 'length', 'timeFrame': '24hour', 'description': 'neonatal length in cm'}, {'measure': 'Duration of O2-Ventilation (day)', 'timeFrame': '1 year', 'description': 'Duration of O2-Ventilation (day)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CDH, FETO, fetal surgery, long tail FETO'], 'conditions': ['Severe Congenital Diaphragmatic Hernia']}, 'referencesModule': {'references': [{'pmid': '19950374', 'type': 'BACKGROUND', 'citation': 'Tchirikov M, Gatopoulos G, Strohner M, Puhl A, Steetskamp J. Two new approaches in intrauterine tracheal occlusion using an ultrathin fetoscope. Laryngoscope. 2010 Feb;120(2):394-8. doi: 10.1002/lary.20687.'}, {'pmid': '19521091', 'type': 'BACKGROUND', 'citation': 'Tchirikov M. Successful tracheal occlusion using ultrathin fetoscopic equipment combined with real-time three-dimensional ultrasound. Eur Surg Res. 2009;43(2):204-7. doi: 10.1159/000224146. Epub 2009 Jun 10.'}, {'pmid': '19658113', 'type': 'BACKGROUND', 'citation': 'Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.'}]}, 'descriptionModule': {'briefSummary': "Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung growth in CDH fetuses avoiding the development of lung hypoplasia.\n\nSome complications after sucsessfull FETO before delivery occur because of technical difficulties during the extraction of the balloon from the trachea, leading to asphyxia, worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO directly related to difficulties with the removal of the intratracheal balloon. The risk of emergent balloon removal was published to be very high (39%-56%).\n\nOur new technique exploits the fetal ability to removal the intratracheal balloon which has been implanted for the treatment of severe CDH before the delivery, avoiding many risks associated with balloon extraction and a second fetoscopy.\n\nThe study will be performed on 20 fetuses with severe CDH. Before the FETO the total fetal lung volume ratio (o/e TFLV) will be measured by fetal MRI (magnetic . Only CDH fetuses with 24-32 weeks' gestation with o/e TFLV \\< 25% or the fetuses with o/e TFLV \\< 35% and liver herniation will be operated Second fetal MRI should be performed in one week after the FETO. The balloon will be extracted by the fetus itself before the delivery, after puncture with 22 gauge needle under ultrasound guiding, during second fetoscopy or using the EXIT (ex utero intrapartum Treatment). Neonatal follow up 12 months.", 'detailedDescription': "Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns, depending on whether stillbirths are included or not. 40 % of all CDH cases show associated malformations and chromosomal abnormalities and/or syndromes take place in 10-20%. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. Liver herniation into the thorax, is also a negative predictor of fetal survival. In case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung growth in CDH fetuses avoiding the development of lung hypoplasia.\n\nA common complication of fetal surgery is the preterm premature rupture of membranes (PPROM) leading to preterm delivery. The next problem occurs because of technical difficulties during the extraction of the balloon from the trachea, leading to asphyxia, worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO directly related to difficulties with the removal of the intratracheal balloon. The risk of emergent balloon removal was published to be very high (39%-56%).\n\nOur new long tail balloon exploits the fetal ability to removal the intratracheal balloon which has been implanted for the treatment of severe CDH before the delivery, avoiding many risks associated with balloon extraction and a second fetoscopy.\n\nThe study will be performed on 20 fetuses with severe CDH with total fetal lung volume ratio (o/e TFLV) \\< 25% or with o/e TFLV \\< 35% combined with liver herniation into the thorax. The lung volume will be estimated by fetal MRI. The selected fetuses with severe CDH at 24-32 weeks' gestation will be operated.\n\nBefore the Long tail FETO the 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg atropine will be applicated i.m. to the CDH fetus using 22 gauge needle under ultrasound control. The monofilament 5-0 polypropylene suture of 7 cm will be fixed to the balloon (Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France) and the FETO will be performed. The fetoscope (Karl Storz, Tuttlingen, Germany) with a diameter of 1.3 mm will be percutaneously inserted through a sheath into the uterus and then into the fetal trachea. The fetoscope will be removed and the long tail balloon will be inserted under 4-D ultrasound guidance.The position of the balloon and suture will be controlled by fetoscopy and sonography.\n\nSecond fetal MRI should be performed in one week after the FETO. The balloon must be extracted before the delivery.\n\nPossibilities of the Long tail extraction:\n\n1. The fetus is able to extract the balloon from the trachea after FETO, by pulling the balloons' long tail, at the end of pregnancy;\n2. by fetus itself after balloon puncture with 22 gauge needle under ultrasound guiding;\n3. during second fetoscopy;\n4. or using the EXIT procedure.\n\nThe CDH will be closed with / or without a patch. The follow up examinations will be performed at 6 and 12 months of age the baby."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maternal age of 18-48 years\n* severe CDH with MRI measured observed/expected total fetal lung volume (o/e TFLV) \\< 25% or \\< 35% in combination with a liver herniation into the thorax.\n\nExclusion Criteria:\n\n* fetuses with other letal morphological abnormalities\n* fetuses with chromosomal abnormalities\n* severe maternal illneses'}, 'identificationModule': {'nctId': 'NCT03431792', 'acronym': 'LongTailFETO', 'briefTitle': 'FETO With Long Tail Balloon for a Treatment of Severe CDH', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'The Intrauterine Fetoscopic Tracheal Occlusion (FETO) With Long Tail Balloon for a Treatment of Severe Congenital Diaphragmatic Hernia (CDH)', 'orgStudyIdInfo': {'id': '2017-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-Tail-FETO', 'description': 'Fetus with severe CDH and o/e TFLV Ratio of \\< 25% or \\< 35% with liver herniation. The Long tail FETO will performed between 26 and 30 weeks of gestation.\n\nThe MRI control will be perfirmed ar 32-34 weeks of gestation. Long Tail FETO: fetal i.m. application of 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg atropine. ("Long-Tail" Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France). The fetoscope (Karl Storz, Tuttlingen, Germany) with a diameter of 1.3 mm, will be percutaneously inserted through a sheath into the uterus and then into the fetal trachea. The fetoscope will be removed and the balloon will be inserted under 4-D ultrasound guidance into the fetal trachea. The position of the balloon and suture will be visualized using the fetoscopy.\n\nThe Long tail ballon will be removed by a second FETO after 34 weeks\' gestation or bei the fetus itself with or without of the long tail balloon puncture with 22 gauge needle. The EXIT procedure is also possible.', 'interventionNames': ['Device: Long Tail Balloon']}], 'interventions': [{'name': 'Long Tail Balloon', 'type': 'DEVICE', 'description': 's. description of experimental Arm', 'armGroupLabels': ['Long-Tail-FETO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Tchirikov, MD, PhD', 'role': 'CONTACT', 'email': 'geburtshilfe@uk-halle.de', 'phone': '0493455573250'}, {'name': 'Kathrin Reinsdorf', 'role': 'CONTACT', 'email': 'reinsdorf@uk-halle.de', 'phone': '0493455573245'}], 'facility': 'Center of Fetal Surgery, Clinic of Obstetrics and Perinatal Medicine, Martin-Luther-University Halle-Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'centralContacts': [{'name': 'Michael Tchirikov, MD, PhD', 'role': 'CONTACT', 'email': 'michael.tchirikov@uk-halle.de', 'phone': '+49-345-557-3250'}, {'name': 'Michael Bergner, MD', 'role': 'CONTACT', 'email': 'michael.bergner@uk-halle.de'}], 'overallOfficials': [{'name': 'Michael Tchirikov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germany, Center of Fetal Surgery, Martin-Luther University Halle-Wittenberg'}]}, 'ipdSharingStatementModule': {'url': 'https://web.uk-halle.de/index.php?id=7769', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'when summary data are published', 'ipdSharing': 'YES', 'description': 'All patients:\n\nonly the Nr. of the patient will be available, diagnosis, diaphragmatic hernia left or right, liver herniation, o/e total volume lung ration (%), gestational age at the Operation (long tail FETO), gestational age of the delivery, PPROM (yes/no), APGAR, art. pH, weight.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of University Clinic of Obstetrics and Prenatal Medicine, Center of Fetal Surgery', 'investigatorFullName': 'Michael Tchirikov MD, PhD', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}