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Ultrasound Device

Home Ultrasound users for Perinatal Care

N/A
Waitlist Available
Led By Reem Abu-Rustum, MD
Research Sponsored by PulseNmore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Singleton gestation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up test to be conducted during week >27-38 of pregnancy
Awards & highlights

Study Summary

This trial is designed to study the safety and feasibility of a new medical device when used by pregnant individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are pregnant with only one baby.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~test to be conducted during week >27-38 of pregnancy
This trial's timeline: 3 weeks for screening, Varies for treatment, and test to be conducted during week >27-38 of pregnancy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth
Comparison of device derived presence or absence of fetal cardiac activity to ground truth
Secondary outcome measures
Ability to assess fetal presentation from device derived input will be compared to the ground truth
Ability to assess placental location from device derived input will be compared to the ground truth
Ability to detect fetal breathing from device derived input will be compared to the ground truth
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Home Ultrasound usersExperimental Treatment1 Intervention
Single Arm home ultrasound in pregnant women users
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulsenmore ES home ultrasound device
2022
N/A
~190

Find a Location

Who is running the clinical trial?

PulseNmoreLead Sponsor
2 Previous Clinical Trials
220 Total Patients Enrolled
Reem Abu-Rustum, MDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for enrollment in this clinical trial?

"This clinical trial necessitates the involvement of 180 eligible patients. Those interested in taking part can visit either Center for Fetal Medicine and Women's Ultrasound located in Los Angeles, California or one of the Mount Sinai Hospital System locations situated in New york, New York."

Answered by AI

What is the operative aim of this medical research?

"The primary goal of the clinical trial, which will take place between weeks 14 and 38 in gestation, is to contrast data derived from a device with factual evidence regarding fetal cardiac activity. Secondary outcomes evaluate if the device can recognize fetal presentation compared to physical scans, indicates breathing through comparison to traditional ultrasound readings, and ascertains movement when juxtaposed against real-time observations."

Answered by AI

Are there vacancies open to individuals for participation in this examination?

"Indeed, the information stored on clinicaltrials.gov suggests that this research project is still open for recruitment. It was originally posted in April 14th 2022 and updated most recently in March 27th 2023 with a target of 180 participants at 4 clinics."

Answered by AI

How many settings are hosting this clinical investigation?

"Participants for this trial can be recruited at Center for Fetal Medicine and Women's Ultrasound in Los Angeles, Mount Sinai Hospital System in New york, University of Florida College of Medicine in Gainesville as well as an additional four sites."

Answered by AI
~64 spots leftby Mar 2025