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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

RecruitingNAAges 18 Years - anyFemaleUltrasound-Innovation Medtech, S.L.
NCT06968364 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: Does the Cervisense TPTL device predict spontaneous preterm birth within 7 days? Is the device safe and technically reliable in a hospital setting? Researchers will conduct a Pilot Study (randomized, dual-arm) followed by a Pivotal Study (single-arm) to assess technical feasibility and predictive performance. Participants 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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female ≥18 years * Singleton pregnancy * Live fetus, 28w+0d-36w+6d GA * Intact membranes * Cervical dilatation \<2 cm * Signed informed consent * Regular uterine contractions (≥8/60 min) (Pivotal only) Exclusion Criteria: * Latex allergy * Prolapsed membranes * Fetal malformation * Fetal infection * Vaginal bleeding (severe or persistent) * Cervical cerclage * Müllerian anomalies * Pessary use * Regular uterine contractions (reported by patient) (Pilot only) * History of preterm birth or TPTL (Pilot only) * Vasa/placenta previa (Pilot only) * Gastrointestinal or urinary infections (Pivotal only)
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What it tests

  • Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.
  • Transvaginal ultrasound
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Where

14 sites
H. Universitario de A Coruña
A Coruña, Spain
H. Clínic de Barcelona
Barcelona, Spain
H. Sant Joan de Déu
Barcelona, Spain
H. Vall d'Hebron
Barcelona, Spain
H. Universitario de Basurto
Bilbao, Spain
H. Universitario de Cruces
Bilbao, Spain
H. Universitario de Donostia
Donostia / San Sebastian, Spain
H. Universitario San Cecilio
Granada, Spain

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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