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
Ultrasound-Innovation Medtech, S.L.
457 participants
May 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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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Interventions
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.
Cervicometry measured with transvaginal ultrasound
Locations(14)
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NCT06968364