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NCT Number: 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

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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Key information

Conditions

Threatened Preterm Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

H. Universitario de A Coruña, A Coruña, Spain

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About this study

The study titled "Evaluation of the safety and the preterm birth predictive capacity of the clinical investigation device 'Cervisense TPTL': an international clinical study" is designed to assess both the safety and performance of the Cervisense TPTL device in predicting spontaneous preterm birth. It is being conducted across various Gynaecology, Obstetrics, and Emergency Services in hospitals throughout Spain and Germany.

Cervisense TPTL is the investigational product being evaluated. It includes two components: the Cervisense Intravaginal Probe V0.1, which measures cervical stiffness, and the Fine Birth algorithm, which combines the measurement with clinical data to assess the short-term risk of spontaneous preterm labor.

The device is intended for use in pregnant women showing symptoms of threatened preterm labor (TPTL), with intact amniotic membranes and a single fetus, between 28 weeks and 36 weeks plus 6 days of gestation. Its purpose is to determine the risk of spontaneous preterm birth within the following 7 days.

The clinical investigation is structured in two phases. The pilot study is a randomized, dual-arm, open-label, interventional, multi-centre study conducted in Spain. Participants are randomized 1:1 to receive either the standard of care or the Cervisense evaluation. The pivotal study is non-randomized and single-arm, also open-label and interventional, conducted at a larger scale across multiple centres in both Spain and Germany.

The main goal is to confirm that the device is safe to use and reliable in clinical settings. For safety, all adverse events associated with the use of the device are documented and analyzed in terms of severity, duration, and required intervention. Special attention is given to potential complications such as tissue trauma or infection. To ensure unbiased evaluation, a Clinical Events Committee and a Data Safety Monitoring Board have been established to independently review adverse events and guide study continuation.

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.

Device

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

Device

Cervicometry measured with transvaginal ultrasound

Primary outcomes

  1. ≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)

    Time frame: 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.

  2. Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases)

    Time frame: 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.

  3. Technical problems ratio (Pilot Phase)

    Time frame: From enrollment until the use of the device

    To report less than 10 technical problems that impeded the physician from performing cervical stiffness measurements

  4. Probe repeatability (Pilot Phase)

    Time frame: From enrollment until the use of the device

    To have an average repeatability rate greater than 75%

  5. Valid measurements obtained (Pilot Phase)

    Time frame: From enrollment until the use of the device

    To achieve more than 80% of valid cases among the measures obtained

Secondary outcomes

  1. Monitor labour progression indicators (Pilot and Pivotal Phases)

    Time frame: From enrollment until the 14-days follow-up

    To monitor key indicators of labour progression, such as frequency and intensity of contractions, and foetal descent after using the device to determine based on clinical criteria if there are any significant changes in labour progression indicators that could be attributed to its use.

  2. Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)

    Time frame: From enrollment until the 14-days follow-up

    To monitor key indicators of potential trauma caused by the device entering the vagina or contacting the cervix, such as bruising (petechiae) or bleeding. Visual evaluation of the vagina and the cervix will be performed before and immediately after the use of the device and any significant changes that could be attributed to its use will be documented.

  3. VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)

    Time frame: From enrollment until the use of the device

    To achieve a VAS score attributed to the use of Cervisense Intravaginal Probe V0.1 m≤ 3, which is equivalent to mild or no pain.

  4. Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)

    Time frame: From enrollment until delivery

    To estimate and report Cervisense TPTL Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) in screening for spontaneous preterm birth within the next 10 and 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.

  5. Subgroup analysis (gestational age, obstetric history) (Pivotal Phase)

    Time frame: From enrollment until delivery

    To estimate and report Cervisense TPTL Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) in screening for spontaneous preterm birth within the next 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.

  6. Training performance (Pivotal Phase)

    Time frame: From enrollment until delivery

    To evaluate the performance of the device in different subgroups (gestational age, previous pregnancies, previous deliveries previous miscarriages, previous episode of TPTL).

  7. Operator satisfaction (SUS) (Pilot and Pivotal Phases)

    Time frame: From enrollment until the use of the device

    To measure the operator degree of satisfaction with the Cervisense technique with the SUS (System Usability Scale).

  8. Comparison with PartoSure and cervical length (at 7, 10, 14 days) (Pivotal Phase)

    Time frame: From enrollment until delivery

    To compare the Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) of Cervisense TPTL with the ones obtained with PartoSure test and cervical length within the next 7, 10 and 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.

  9. Degree of success obtained during the use of the Cervisense Intravaginal Probe (Pilot Phase)

    Time frame: From enrollment until the use of the device

    To measure the degree of success obtained during the use of Cervisense Intravaginal Probe V0.1: device ID, operator profile and code, number of repetitions, % repeatability of the measurement, incidents and probe cover breakage

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Maroto Ferrer

CONTACT

[email protected]

+34 747 44 15 38

Sponsors and collaborators

Lead sponsor

Ultrasound-Innovation Medtech, S.L.

Industry

Registry information

Official study title

Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study

Acronym: FB-CT2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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