Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 457
- 试验地点
- 14
- 主要终点
- ≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: From enrollment until the use of the device
To have an average repeatability rate greater than 75%
Valid measurements obtained (Pilot Phase)
时间窗: From enrollment until the use of the device
To achieve more than 80% of valid cases among the measures obtained
次要结局
- Monitor labour progression indicators (Pilot and Pivotal Phases)(From enrollment until the 14-days follow-up)
- Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)(From enrollment until the 14-days follow-up)
- VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)(From enrollment until the use of the device)
- Training performance (Pivotal Phase)(From enrollment until delivery)
- Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)(From enrollment until delivery)
- Subgroup analysis (gestational age, obstetric history) (Pivotal Phase)(From enrollment until delivery)
- Operator satisfaction (SUS) (Pilot and Pivotal Phases)(From enrollment until the use of the device)
- Comparison with PartoSure and cervical length (at 7, 10, 14 days) (Pivotal Phase)(From enrollment until delivery)
- Degree of success obtained during the use of the Cervisense Intravaginal Probe (Pilot Phase)(From enrollment until the use of the device)