Clinical trial 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
Official title: Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Threatened Preterm Labor
Lead sponsor: Ultrasound-Innovation Medtech, S.L.
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 457
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed description: 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)

Eligibility criteria: 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)

Primary outcomes:
measure: ≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
timeFrame: From enrollment until delivery
measure: Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases)
timeFrame: From enrollment until delivery
measure: Technical problems ratio (Pilot Phase)
timeFrame: From enrollment until the use of the device
measure: Probe repeatability (Pilot Phase)
timeFrame: From enrollment until the use of the device
measure: Valid measurements obtained (Pilot Phase)
timeFrame: From enrollment until the use of the device
Secondary outcomes:
measure: Monitor labour progression indicators (Pilot and Pivotal Phases)
timeFrame: From enrollment until the 14-days follow-up
measure: Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)
timeFrame: From enrollment until the 14-days follow-up
measure: VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)
timeFrame: From enrollment until the use of the device
measure: Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)
timeFrame: From enrollment until delivery
measure: Subgroup analysis (gestational age, obstetric history) (Pivotal Phase)
timeFrame: From enrollment until delivery
measure: Training performance (Pivotal Phase)
timeFrame: From enrollment until delivery
measure: Operator satisfaction (SUS) (Pilot and Pivotal Phases)
timeFrame: From enrollment until the use of the device
measure: Comparison with PartoSure and cervical length (at 7, 10, 14 days) (Pivotal Phase)
timeFrame: From enrollment until delivery
measure: Degree of success obtained during the use of the Cervisense Intravaginal Probe (Pilot Phase)
timeFrame: From enrollment until the use of the device
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: H. Universitario de A Coruña
city: Barcelona
country: Spain
facility: H. Clínic de Barcelona
city: Barcelona
country: Spain
facility: H. Sant Joan de Déu
city: Barcelona
country: Spain
facility: H. Vall d'Hebron
city: Bilbao
country: Spain
facility: H. Universitario de Basurto
city: Bilbao
country: Spain
facility: H. Universitario de Cruces
city: Donostia
country: Spain
facility: H. Universitario de Donostia
city: Granada
country: Spain
facility: H. Universitario San Cecilio
city: Las Palmas de Gran Canaria
country: Spain
facility: H. Materno Infantil de Gran Canaria
city: Madrid
country: Spain
facility: H. General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: H. Universitario de Torrejón
city: Madrid
country: Spain
facility: H. Universitario La Paz
city: Murcia
country: Spain
facility: H. Virgen Arrixaca
city: Málaga
country: Spain
facility: H. Universitario de Málaga
Study officials:
References:
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