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

NARecruitingINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

May 10, 2025

Primary Completion Date

February 15, 2027

Study Completion Date

April 1, 2027

Conditions
Threatened Preterm Labor
Interventions
DEVICE

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.

DEVICE

Transvaginal ultrasound

Cervicometry measured with transvaginal ultrasound

Trial Locations (14)

Unknown

NOT_YET_RECRUITING

H. Universitario de A Coruña, A Coruña

NOT_YET_RECRUITING

H. Clínic de Barcelona, Barcelona

NOT_YET_RECRUITING

H. Sant Joan de Déu, Barcelona

NOT_YET_RECRUITING

H. Vall d'Hebron, Barcelona

RECRUITING

H. Universitario de Basurto, Bilbao

RECRUITING

H. Universitario de Cruces, Bilbao

NOT_YET_RECRUITING

H. Universitario de Donostia, Donostia / San Sebastian

RECRUITING

H. Universitario San Cecilio, Granada

NOT_YET_RECRUITING

H. Materno Infantil de Gran Canaria, Las Palmas de Gran Canaria

NOT_YET_RECRUITING

H. General Universitario Gregorio Marañón, Madrid

RECRUITING

H. Universitario de Torrejón, Madrid

NOT_YET_RECRUITING

H. Universitario La Paz, Madrid

NOT_YET_RECRUITING

H. Universitario de Málaga, Málaga

NOT_YET_RECRUITING

H. Virgen Arrixaca, Murcia

All Listed Sponsors
lead

Ultrasound-Innovation Medtech, S.L.

INDUSTRY