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

NCT07223996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Fetal Monitoring

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.

Sponsors & Collaborators

  • Nestmedic Spolka Akcyjna

    lead INDUSTRY

Principal Investigators

  • Anna Szopa · Nestmedic Spolka Akcyjna

  • Jacek Gnich · Nestmedic Spolka Akcyjna

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-01-30
Completion
2026-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223996 on ClinicalTrials.gov