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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Transvaginal ultrasound: Cervicometry measured with transvaginal ultrasound

Study 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

Primary outcome measure(s)

• ≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase) — From enrollment until delivery
  It will be determined in terms of accuracy, specifically with Specificity and Sensitivity as primary endpoints. Cervisense TPTL will be considered effective in screening for preterm birth risk if the validation study demonstrates at least 90% Specificity and 50% Sensitivity in detecting spontaneous preterm birth within the next 7 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labor (TPTL) presenting to the emergency department.
• Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases) — From enrollment until delivery
  To document and analyse all adverse events related to the device use, categorized by severity, duration, and required intervention. Exhaustive monitoring of complications directly attributable to the device or its usage, such as tissue damage or active infection.
• Technical problems ratio (Pilot Phase) — From enrollment until the use of the device
  To report less than 10 technical problems that impeded the physician from performing cervical stiffness measurements
• Probe repeatability (Pilot Phase) — From enrollment until the use of the device
  To have an average repeatability rate greater than 75%
• Valid measurements obtained (Pilot Phase) — From enrollment until the use of the device
  To achieve more than 80% of valid cases among the measures obtained

Trial sites (14)