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A Single-center, Single-arm, retrospective-prospective exploratory clinical performance study of an in vitro diagnostic device to evaluate a digital medical device that determines fetal lung maturity by analyzing spectroscopic signals of maternal cervicovaginal samples using a deep learning algorithm

A Single-center, Single-arm, retrospective-prospective exploratory clinical performance study of an in vitro diagnostic device to evaluate a digital medical device that determines fetal lung maturity by analyzing spectroscopic signals of maternal cervicovaginal samples using a deep learning algorithm

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011331
Enrollment
42
Registered
2025-12-15
Start date
2025-12-09
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

EXoPERT corporation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Individuals holding South Korean nationality 2) Individuals who voluntarily provide written informed consent to participate in the study 3) Pregnant women scheduled for cesarean delivery 4) Pregnant women aged 19 years or older 5) Individuals who agree to provide the following clinical information: A. Age B. PG measurement results

Exclusion criteria

Exclusion criteria: Pregnant woman under the age of 18

Design outcomes

Primary

MeasureTime frame
Clinical performance of the FLARM device in predicting fetal lung maturity (AUC);Clinical performance of the FLARM device in predicting fetal lung maturity (sensitivity);Clinical performance of the FLARM device in predicting fetal lung maturity (specificity)—

Secondary

MeasureTime frame
Comparison of fetal lung maturity prediction performance between singleton and twin pregnancies.;Evaluation of the FLARM device’s fetal lung maturity prediction performance according to maternal age groups.;Evaluation of the FLARM device’s fetal lung maturity prediction performance according to gestational age.—

Countries

Korea, Republic of

Contacts

Public ContactHeekyung Lee

Seoul National University Bundang Hospital

naich486@naver.com+82-31-787-7266

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 7, 2026