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Pulsenmore ES Device, Efficacy and Safety Assessment

NCT05329077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2023-11-30

No results posted yet for this study

Summary

This is a multicenter, prospective, investigational device study designed to evaluate:

The safety, feasibility, and accuracy of the device, when used by pregnant individuals

Conditions

  • Perinatal Care

Interventions

DEVICE

Pulsenmore ES home ultrasound device

Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters

Sponsors & Collaborators

  • PulseNmore

    lead INDUSTRY

Principal Investigators

  • Reem Abu-Rustum, MD · University of Florida

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2023-06-09
Completion
2023-11-11
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 NCT05329077 on ClinicalTrials.gov