Perinatal CareNCT06442358
Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
A study testing Pulsenmore ES home ultrasound device in people with Perinatal Care, run by PulseNmore at 1 site in United States.
Trial summary
The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Care
- What is being tested?
- Pulsenmore ES home ultrasound device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Singleton pregnancy
- Gestational age ≥ 24 0/7 weeks
- No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
- Ability to understand and sign informed consent in English
- Ability to read and understand instructions in English
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- Ability to hold an ultrasound probe and respond to clinician instructions
- BMI less than 40 at initial prenatal visit
- Scheduled biophysical profile (BPP)
- Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.
Who cannot join
- Multiple gestation
- Known major fetal structural anomaly or aneuploidy
- Known fetal or genetic anomalies
- Ruptured membranes
- Uterine complaints, such as painful contractions
- Maternal concern for decreased fetal movement
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- Not evaluated vaginal bleeding (not including spotting)
- Fetal or maternal criteria that require urgent delivery
- BMI ≥ 40 at initial prenatal visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BPP for ME: Self Biophysical Profile Proof of Concept
The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.
- Conditions
- Perinatal Care
- Being tested
- Pulsenmore ES home ultrasound device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsenmore ES home ultrasound deviceDevice
Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider
| Study group | Role | What they receive |
|---|---|---|
| Single Arm home ultrasound in pregnant women require BPP | Other | Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician Receives: Device: Pulsenmore ES home ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level
Measured: One day
Secondary outcomes (2)
Assess preliminary effectiveness and compare participant results to standard of care BPP
The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP
Measured: One day
Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.
Patients will answer a questionnaire about their experience using Pulsenmore device
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Apr 2024
- Primary completion9 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseNmore
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Alex Peahl, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442358
- Sponsor's protocol ID
- HUM00244136
- Status last verified
- Jun 2025
- First submitted
- 29 May 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BPP for ME: Self Biophysical Profile Proof of Concept
- ClinicalTrials.gov ID
- NCT06442358
- Acronym / sponsor ID
- HUM00244136
- Conditions
- Perinatal Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PulseNmoreIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm home ultrasound in pregnant women require BPP | Other | Device: Pulsenmore ES home ultrasound devicePregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old
- Singleton pregnancy
- Gestational age ≥ 24 0/7 weeks
- No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
- Ability to understand and sign informed consent in English
Key exclusion criteria (9 listed)
- Multiple gestation
- Known major fetal structural anomaly or aneuploidy
- Known fetal or genetic anomalies
- Ruptured membranes
- Uterine complaints, such as painful contractions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsenmore ES home ultrasound devicePulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider | Device | Single Arm home ultrasound in pregnant women require BPP |
Primary outcome
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
Time frame: One day
Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level
2 secondary outcomes
Assess preliminary effectiveness and compare participant results to standard of care BPP
Time frame: One day
Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Peahl, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsenmore ES home ultrasound device in people with Perinatal Care, run by PulseNmore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.