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Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects

NCT03504189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2020-02-18

Study results available
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Summary

This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

Conditions

  • Pregnancy

Interventions

DEVICE

PregSense™

PregSense™ wearable device will be applied for maternal-fetal monitoring

DEVICE

Cardiotocopraphy (CTG)

Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring

Sponsors & Collaborators

  • Nuvo-Group, Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-06-27
Completion
2018-11-08
FDA Device
Yes

Countries

  • United States
  • Germany
  • Israel

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 NCT03504189 on ClinicalTrials.gov