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Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
Sponsor: Nestmedic Spolka Akcyjna
Summary
This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester. The PregnaOne System consists of the Pregnabit Pro device and related software, designed to record fetal heart rate, maternal pulse, and uterine contractions in a home-like environment. The study compares the performance of the PregnaOne System with a similar FDA-cleared at-home monitoring system (the INVU system by Nuvo). Approximately 70 pregnant women will participate at three medical centers in the United States. Each participant will complete one training session and two fetal monitoring sessions during a single study visit.
Key Details
Gender
FEMALE
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2025-09-30
Completion Date
2026-01-30
Last Updated
2026-04-20
Healthy Volunteers
Yes
Conditions
Interventions
PregnaOne System
The PregnaOne System is a non-significant risk (NSR) investigational medical device designed for in-home fetal monitoring. It includes the Pregnabit Pro device and the cloud-based PregnaOne Platform software. The system records fetal heart rate, maternal pulse, and uterine activity, transmitting data to a remote monitoring center for clinical evaluation. During the study, participants will perform two monitoring sessions: 1. Simultaneous use of the PregnaOne and INVU systems. 2. Independent monitoring using only the PregnaOne System. The study evaluates the usability, safety, and performance of the PregnaOne System in comparison with a reference device.
Locations (3)
Christie Clinic, LLC
Champaign, Illinois, United States
The Iowa Clinic, P.C.
West Des Moines, Iowa, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States