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Ultrasound Device

Pulsenmore ES Device, Efficacy and Safety Assessment

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
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
No Placebo-Only Group

Summary

This trial is testing a new medical device to see if it is safe and effective for pregnant individuals.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
4 Previous Clinical Trials
302 Total Patients Enrolled
1 Trials studying Perinatal Care
25 Patients Enrolled for Perinatal Care
Reem Abu-Rustum, MDPrincipal InvestigatorUniversity of Florida
~51 spots leftby Dec 2025
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