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
NCT ID: NCT06968364
Last Updated: 2025-05-13
Study Results
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Basic Information
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RECRUITING
NA
457 participants
INTERVENTIONAL
2025-05-10
2027-04-01
Brief Summary
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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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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Cervisense
Cervisense arm: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.
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.
Control arm (only in Pilot Phase)
Control arm: Cervicometry measured with transvaginal ultrasound
Transvaginal ultrasound
Cervicometry measured with transvaginal ultrasound
Interventions
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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.
Transvaginal ultrasound
Cervicometry measured with transvaginal ultrasound
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
Yes
Sponsors
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Ultrasound-Innovation Medtech, S.L.
INDUSTRY
Responsible Party
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Locations
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H. Universitario de A Coruña
A Coruña, , Spain
H. Clínic de Barcelona
Barcelona, , Spain
H. Sant Joan de Déu
Barcelona, , Spain
H. Vall d'Hebron
Barcelona, , Spain
H. Universitario de Basurto
Bilbao, , Spain
H. Universitario de Cruces
Bilbao, , Spain
H. Universitario de Donostia
Donostia / San Sebastian, , Spain
H. Universitario San Cecilio
Granada, , Spain
H. Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, , Spain
H. General Universitario Gregorio Marañón
Madrid, , Spain
H. Universitario de Torrejón
Madrid, , Spain
H. Universitario La Paz
Madrid, , Spain
H. Universitario de Málaga
Málaga, , Spain
H. Virgen Arrixaca
Murcia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Papiernik E, Bouyer J, Collin D, Winisdoerffer G, Dreyfus J. Precocious cervical ripening and preterm labor. Obstet Gynecol. 1986 Feb;67(2):238-42. doi: 10.1097/00006250-198602000-00014.
Parra-Saavedra M, Gomez L, Barrero A, Parra G, Vergara F, Navarro E. Prediction of preterm birth using the cervical consistency index. Ultrasound Obstet Gynecol. 2011 Jul;38(1):44-51. doi: 10.1002/uog.9010.
Molina FS, Pardo L, Munoz MD, Aiartzaguena A, Valladolid A, Blanco JE, Burgos J, Gil MM. Reproducibility and usability assessment of the novel Fine Birth device for threatened preterm labor diagnosis. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100982. doi: 10.1016/j.ajogmf.2023.100982. Epub 2023 Apr 23.
Melchor JC, Navas H, Marcos M, Iza A, De Diego M, Rando D, Melchor I, Burgos J. Predictive performance of PAMG-1 vs fFN test for risk of spontaneous preterm birth in symptomatic women attending an emergency obstetric unit: retrospective cohort study. Ultrasound Obstet Gynecol. 2018 May;51(5):644-649. doi: 10.1002/uog.18892. Epub 2018 Mar 26.
Melchor JC, Khalil A, Wing D, Schleussner E, Surbek D. Prediction of preterm delivery in symptomatic women using PAMG-1, fetal fibronectin and phIGFBP-1 tests: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Oct;52(4):442-451. doi: 10.1002/uog.19119. Epub 2018 Sep 4.
Masso P, Callejas A, Melchor J, Molina FS, Rus G. In Vivo Measurement of Cervical Elasticity on Pregnant Women by Torsional Wave Technique: A Preliminary Study. Sensors (Basel). 2019 Jul 24;19(15):3249. doi: 10.3390/s19153249.
Jackson GM, Ludmir J, Bader TJ. The accuracy of digital examination and ultrasound in the evaluation of cervical length. Obstet Gynecol. 1992 Feb;79(2):214-8. doi: 10.3109/01443619209013646.
Horinouchi T, Yoshizato T, Muto M, Fujii M, Kozuma Y, Shinagawa T, Morokuma S, Kakuma T, Ushijima K. Gestational age-related changes in shear wave speed of the uterine cervix in normal pregnancy at 12-35 weeks' gestation. J Perinat Med. 2019 May 27;47(4):393-401. doi: 10.1515/jpm-2018-0250.
Holcomb WL Jr, Smeltzer JS. Cervical effacement: variation in belief among clinicians. Obstet Gynecol. 1991 Jul;78(1):43-5.
Goldenberg RL, Mercer BM, Meis PJ, Copper RL, Das A, McNellis D. The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth. NICHD Maternal Fetal Medicine Units Network. Obstet Gynecol. 1996 May;87(5 Pt 1):643-8. doi: 10.1016/0029-7844(96)00035-x.
Carlson LC, Feltovich H, Palmeri ML, Dahl JJ, Munoz del Rio A, Hall TJ. Estimation of shear wave speed in the human uterine cervix. Ultrasound Obstet Gynecol. 2014 Apr;43(4):452-8. doi: 10.1002/uog.12555. Epub 2014 Mar 12.
Callejas A, Gomez A, Faris IH, Melchor J, Rus G. Kelvin-Voigt Parameters Reconstruction of Cervical Tissue-Mimicking Phantoms Using Torsional Wave Elastography. Sensors (Basel). 2019 Jul 25;19(15):3281. doi: 10.3390/s19153281.
BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
Other Identifiers
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FB-CT2
Identifier Type: -
Identifier Source: org_study_id
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