Innitius, a medtech company developing diagnostic solutions in women’s health, has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) to begin its pivotal clinical study for Cervisense TPTL, a device designed to improve diagnosis in women with threatened preterm labor symptoms.
The study, titled “Evaluation of the safety and the preterm birth predictive capacity of the clinical investigation device ‘Cervisense TPTL’: an international clinical study,” will enroll 457 patients across multiple European hospitals. The research will initially include 14 centers in Spain, with three additional German sites expected to join by the end of 2025.
The clinical investigation is structured in two parts and will be conducted within standard hospital care settings. The pilot phase, a randomized, dual-arm, open-label interventional study, is launching this April across four Spanish hospitals with an expected recruitment period of approximately six months. The pivotal phase will follow, expanding to all 14 Spanish hospitals and the three centers in Germany, running as a single-arm, non-randomized, open-label interventional study for approximately 14 months.
Cervisense uses torsional wave technology to measure cervical tissue consistency, which serves as a biomarker for early detection of preterm labor. The study aims to assess both the safety and predictive accuracy of the device in identifying preterm birth risk in symptomatic women.
This new study builds on previous clinical research completed in 2024, which included 400 patients across 10 hospitals and demonstrated promising safety and performance outcomes for the device.
Participating Spanish hospitals include major medical centers such as Hospital Universitario San Cecilio, Hospital Clínic de Barcelona, Hospital Vall d’Hebron, Hospital Universitario La Paz, and Hospital General Universitario Gregorio Marañón, among others.
