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COMPLETED
NCT07223996
NA

Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study

Sponsor: Nestmedic Spolka Akcyjna

View on ClinicalTrials.gov

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

Interventions

DEVICE

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