[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590511":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":210,"collaborators":26,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":220,"sex":221,"minAge":222,"maxAge":26,"enrollmentInfo":223,"targetDuration":26,"studyType":226,"phases":227,"briefSummary":229,"conditions":230,"keywords":26,"overallStatus":90,"whyStopped":26,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},{"fullName":5,"class":6},"Ultrasound-Innovation Medtech, S.L.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cervisense","EXPERIMENTAL","Cervisense arm: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.",[13],"Device: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm (only in Pilot Phase)","ACTIVE_COMPARATOR","Control arm: Cervicometry measured with transvaginal ultrasound",[19],"Device: Transvaginal ultrasound",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.","The Cervisense Intravaginal Probe V0.1 measures cervical stiffness. It is an in-vivo predictive technology that, by using torsional waves, quantifies the mechanical properties (specifically the shear modulus, or resistance of the cervix to shear deformation (kPa), of cervical tissue with extremely high precision. Torsional wave is a type of mechanical wave characterized by a rotational motion and low energy levels (it uses 1000 times less energy than other mechanical waves such as ultrasound). These waves propagate through the tissue, and their propagation speed, which is related to the stiffness (waves propagate faster in stiffer tissues), is measured using piezoelectric sensors.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Transvaginal ultrasound","Cervicometry measured with transvaginal ultrasound",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Alberto Maroto Ferrer","CONTACT","+34 747 44 15 38","alberto.maroto@innitius.com",[38,55,68,78,88,102,112,125,138,151,164,174,184,197],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"H. Universitario de A Coruña","NOT_YET_RECRUITING","A Coruña","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],-8.396,43.37135,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":54},"Nuria Valiño","+34 981 178 000","atencion.paciente.chuac@sergas.es",{"facility":56,"status":40,"city":57,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"H. Clínic de Barcelona","Barcelona",{"type":45,"coordinates":59},[60,61],2.15899,41.38879,{"lat":61,"lon":60},[64],{"name":65,"role":34,"phone":66,"phoneExt":26,"email":67},"Teresa Cobo","+34 93 227 54 00","marvives@clinic.cat",{"facility":69,"status":40,"city":57,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"H. Sant Joan de Déu",{"type":45,"coordinates":71},[60,61],{"lat":61,"lon":60},[74],{"name":75,"role":34,"phone":76,"phoneExt":26,"email":77},"Sílvia Ferrero","+34 93 253 21 00","atenciousuari@sjdhospitalbarcelona.org",{"facility":79,"status":40,"city":57,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"H. Vall d'Hebron",{"type":45,"coordinates":81},[60,61],{"lat":61,"lon":60},[84],{"name":85,"role":34,"phone":86,"phoneExt":26,"email":87},"María del Mar Goya Canino","+34 934 893 000","web@vallhebron.cat",{"facility":89,"status":90,"city":91,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"H. Universitario de Basurto","RECRUITING","Bilbao",{"type":45,"coordinates":93},[94,95],-2.92528,43.26271,{"lat":95,"lon":94},[98],{"name":99,"role":34,"phone":100,"phoneExt":26,"email":101},"Amelia Valladolid Urdangaray","+34 944 006 000","sapu.basurto@osakidetza.eus",{"facility":103,"status":90,"city":91,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"H. Universitario de Cruces",{"type":45,"coordinates":105},[94,95],{"lat":95,"lon":94},[108],{"name":109,"role":34,"phone":110,"phoneExt":26,"email":111},"Jorge Burgos San Cristóbal","946 006 000","hospitalde.cruces@osakidetza.eus",{"facility":113,"status":40,"city":114,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"H. Universitario de Donostia","Donostia \u002F San Sebastian",{"type":45,"coordinates":116},[117,118],-1.97499,43.31283,{"lat":118,"lon":117},[121],{"name":122,"role":34,"phone":123,"phoneExt":26,"email":124},"Miren Arrue Arrue","+34 943 007 000","osid.sapu@osakidetza.eus",{"facility":126,"status":90,"city":127,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"H. Universitario San Cecilio","Granada",{"type":45,"coordinates":129},[130,131],-3.60667,37.18817,{"lat":131,"lon":130},[134],{"name":135,"role":34,"phone":136,"phoneExt":26,"email":137},"Francisca Molina García","+34 958 02 43 43","infoclinicogranada.husc.sspa@juntadeandalucia.es",{"facility":139,"status":40,"city":140,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"H. Materno Infantil de Gran Canaria","Las Palmas de Gran Canaria",{"type":45,"coordinates":142},[143,144],-15.41573,28.10178,{"lat":144,"lon":143},[147],{"name":148,"role":34,"phone":149,"phoneExt":26,"email":150},"Silvia de León Socorro","+34 928 444 000","gerenciachmi@gobiernodecanarias.org",{"facility":152,"status":40,"city":153,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"H. General Universitario Gregorio Marañón","Madrid",{"type":45,"coordinates":155},[156,157],-3.70256,40.4165,{"lat":157,"lon":156},[160],{"name":161,"role":34,"phone":162,"phoneExt":26,"email":163},"Santiago García-Tizón Larroca","+34 91 586 80 00","sap.hgugm@salud.madrid.org",{"facility":165,"status":90,"city":153,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"H. Universitario de Torrejón",{"type":45,"coordinates":167},[156,157],{"lat":157,"lon":156},[170],{"name":171,"role":34,"phone":172,"phoneExt":26,"email":173},"Maria del Mar Gil Mira","+34 91 626 26 00","informacioncitas@torrejonsalud.com",{"facility":175,"status":40,"city":153,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":176,"geoPoint":178,"contacts":179},"H. Universitario La Paz",{"type":45,"coordinates":177},[156,157],{"lat":157,"lon":156},[180],{"name":181,"role":34,"phone":182,"phoneExt":26,"email":183},"Marcos Javier Cuerva González","+34 91 727 70 00","comunicacion.hulp@salud.madrid.org",{"facility":185,"status":40,"city":186,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"H. Universitario de Málaga","Málaga",{"type":45,"coordinates":188},[189,190],-4.42034,36.72016,{"lat":190,"lon":189},[193],{"name":194,"role":34,"phone":195,"phoneExt":26,"email":196},"Jesús Jiménez López","+34 951 290 000","unidadinformacion.hvv.sspa@juntadeandalucia.es",{"facility":198,"status":40,"city":199,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"H. Virgen Arrixaca","Murcia",{"type":45,"coordinates":201},[202,203],-1.13004,37.98704,{"lat":203,"lon":202},[206],{"name":207,"role":34,"phone":208,"phoneExt":26,"email":209},"José Eliseo Blanco Carnero","+34 968 36 95 00","sau.area1@carm.es",{"type":211,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100590511","fb-ct2-includes-two-prospective-multi-centre-studies-with-a-medical-device-in-hospital-settings-a-randomized-dual-arm-open-label-pilot-study-in-spain-followed-by-a-single-arm-non-randomized-open-label-international-pivotal-study-100590511",false,"NCT06968364","FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study","Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study","FB-CT2","Inclusion Criteria:\n\n* Female ≥18 years\n* Singleton pregnancy\n* Live fetus, 28w+0d-36w+6d GA\n* Intact membranes\n* Cervical dilatation \\\u003C2 cm\n* Signed informed consent\n* Regular uterine contractions (≥8\u002F60 min) (Pivotal only)\n\nExclusion Criteria:\n\n* Latex allergy\n* Prolapsed membranes\n* Fetal malformation\n* Fetal infection\n* Vaginal bleeding (severe or persistent)\n* Cervical cerclage\n* Müllerian anomalies\n* Pessary use\n* Regular uterine contractions (reported by patient) (Pilot only)\n* History of preterm birth or TPTL (Pilot only)\n* Vasa\u002Fplacenta previa (Pilot only)\n* Gastrointestinal or urinary infections (Pivotal only)",true,"FEMALE","18 Years",{"count":224,"type":225},457,"ESTIMATED","INTERVENTIONAL",[228],"NA","The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm labor (TPTL), between 28+0 and 36+6 weeks of gestation. The main questions it aims to answer are:\n\nDoes the Cervisense TPTL device predict spontaneous preterm birth within 7 days?\n\nIs the device safe and technically reliable in a hospital setting?\n\nResearchers will conduct a Pilot Study (randomized, dual-arm) followed by a Pivotal Study (single-arm) to assess technical feasibility and predictive performance.\n\nParticipants will undergo an intravaginal measurement of cervical stiffness using the Cervisense Intravaginal Probe. They will be followed for 14 days after the assessment to record delivery outcomes and any adverse events.",[231],"Threatened Preterm Labor","2025-05-05",{"date":234,"type":235},"2025-05-13","ACTUAL",{"date":237,"type":225},"2025-05-10",{"date":239,"type":225},"2027-04-01",{"name":5,"class":6},14]