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Ultrasound Device

Home Ultrasound Device for Perinatal Care

N/A
Recruiting
Led By Alex Peahl, MD
Research Sponsored by PulseNmore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gestational age ≥ 24 0/7 weeks
Age ≥ 18 years old
Must not have
Known fetal or genetic anomalies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights

Summary

This trial aims to see if pregnant patients can use a home ultrasound device with guidance from a remote clinician to complete a Bio Physical Score test.

Who is the study for?
This clinical trial is for pregnant individuals who are currently undergoing antenatal testing. The details regarding specific inclusion and exclusion criteria have not been provided, so it's important to contact the study organizers for detailed eligibility requirements.
What is being tested?
The trial is evaluating if pregnant patients can perform a Biophysical Profile (BPP), which assesses fetal health, using the Pulsenmore ES home ultrasound device with remote guidance from clinicians.
What are the potential side effects?
Potential side effects are not specified in the provided information. However, as this involves non-invasive ultrasound technology, risks may be minimal but should be discussed with healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 24 weeks pregnant.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My pregnancy has a diagnosed genetic or fetal anomaly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being
Secondary outcome measures
Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.
Assess preliminary effectiveness and compare participant results to standard of care BPP

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm home ultrasound in pregnant women require BPPExperimental Treatment1 Intervention
Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician
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
465 Total Patients Enrolled
1 Trials studying Perinatal Care
188 Patients Enrolled for Perinatal Care
University of MichiganOTHER
1,833 Previous Clinical Trials
6,423,103 Total Patients Enrolled
Alex Peahl, MDPrincipal InvestigatorUniversity of Michigan
~0 spots leftby Sep 2024
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