[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ultrasound-Innovation Medtech, S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},457,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Threatened Preterm Labor","RECRUITING","2025-05-05",{"date":32,"type":33},"2025-05-13","ACTUAL",{"date":35,"type":22},"2025-05-10",{"date":37,"type":22},"2027-04-01",{"name":39,"class":40},"Ultrasound-Innovation Medtech, S.L.","INDUSTRY",14,""]