Perinatal CareNCT05329077
Pulsenmore ES Device, Efficacy and Safety Assessment
A study testing Pulsenmore ES home ultrasound device in people with Perinatal Care, run by PulseNmore at 4 sites in United States.
Trial 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 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
- 188 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2022to 11 Nov 2023
- 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
- Singleton gestation.
- Gestational age >14 weeks with a prior scan demonstrating fetal viability and confirming dates.
- English or Spanish speaking.
- Ability to understand and sign the informed consent (available in English and Spanish).
- Ability to read and understand instructions that are required for equipment use (instructions available in both languages).
Who cannot join
- Multiple gestations.
- BMI >40.
- Known fetal and genetic anomalies.
- Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash).
- Subjects allergic to the ultrasound probe materials.
- Non-English/ non-Spanish speaking.
- Unable to provide consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Florida College of Medicine
Gainesville, Florida, 32601-0294
Center for Fetal Medicine and Women's Ultrasound
Los Angeles, California, 90048
Mount Sinai Hospital System
New York, New York, 10029
About this study
Official title: A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women
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
- 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
Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters
| Study group | Role | What they receive |
|---|---|---|
| Home Ultrasound users | Other | Single Arm home ultrasound in pregnant women users Receives: Device: Pulsenmore ES home ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of device derived presence or absence of fetal cardiac activity to ground truth
The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan)
Measured: Test to be conducted during week 14-38 of pregnancy
Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth
Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan)
Measured: Test to be conducted during week 14-38 of pregnancy
Secondary outcomes (4)
Ability to assess fetal presentation from device derived input will be compared to the ground truth
Whether fetal presentation could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Measured: Test to be conducted during week 14-38 of pregnancy
Ability to assess placental location from device derived input will be compared to the ground truth
Whether placental location could be assessed or could not be assessed from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Measured: Test to be conducted during week 14-38 of pregnancy
Ability to detect fetal movement from device derived input will be compared to the ground truth
Whether fetal movement could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Measured: Test to be conducted during week 14-38 of pregnancy
Ability to detect fetal breathing from device derived input will be compared to the ground truth
Whether fetal breathing could be detected or could not be detected from device derived input compared to the input from ground truth (in-clinic ultrasound scan)
Measured: Test to be conducted during week >27-38 of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start14 Apr 2022
- Primary completion9 Jun 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseNmore
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reem Abu-Rustum, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329077
- Sponsor's protocol ID
- 2201V1
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG)
Abuhamad A, Zhao Y, Abuhamad S, Sinkovskaya E, Rao R, Kanaan C, Platt L. Standardized Six-Step Approach to the Performance of the Focused Basic Obstetric Ultrasound Examination. Am J Perinatol. 2016 Jan;33(1):90-8. doi: 10.1055/s-0035-1558828. Epub 2015 Aug 3.
PubMed 26238329
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women
- ClinicalTrials.gov ID
- NCT05329077
- Acronym / sponsor ID
- 2201V1
- Conditions
- Perinatal Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- PulseNmoreIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 14 Apr 2022 (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.
This is a multicenter, prospective, investigational device study designed to evaluate:
The safety, feasibility, and accuracy of the device, when used by pregnant individuals
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Ultrasound users | Other | Device: Pulsenmore ES home ultrasound deviceSingle Arm home ultrasound in pregnant women users |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton gestation.
- Gestational age >14 weeks with a prior scan demonstrating fetal viability and confirming dates.
- English or Spanish speaking.
- Ability to understand and sign the informed consent (available in English and Spanish).
- Ability to read and understand instructions that are required for equipment use (instructions available in both languages).
Key exclusion criteria (7 listed)
- Multiple gestations.
- BMI >40.
- Known fetal and genetic anomalies.
- Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash).
- Subjects allergic to the ultrasound probe materials.
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 devicePregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters | Device | Home Ultrasound users |
Primary outcome
Comparison of device derived presence or absence of fetal cardiac activity to ground truth
Time frame: Test to be conducted during week 14-38 of pregnancy
The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan)
Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth
Time frame: Test to be conducted during week 14-38 of pregnancy
Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan)
4 secondary outcomes
Ability to assess fetal presentation from device derived input will be compared to the ground truth
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to assess placental location from device derived input will be compared to the ground truth
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to detect fetal movement from device derived input will be compared to the ground truth
Time frame: Test to be conducted during week 14-38 of pregnancy
Ability to detect fetal breathing from device derived input will be compared to the ground truth
Time frame: Test to be conducted during week >27-38 of pregnancy
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 30 Nov 2023.
- BackgroundGuidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG)
- Background: PubMed 26238329Abuhamad A, Zhao Y, Abuhamad S, Sinkovskaya E, Rao R, Kanaan C, Platt L. Standardized Six-Step Approach to the Performance of the Focused Basic Obstetric Ultrasound Examination. Am J Perinatol. 2016 Jan;33(1):90-8. doi: 10.1055/s-0035-1558828. Epub 2015 Aug 3.
- 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.
Reem Abu-Rustum, MD principal investigator
University of Florida
4 sites 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 4 sites 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 5 inclusion and 7 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Comparison of device derived presence or absence of fetal cardiac activity to ground truth (time frame: Test to be conducted during week 14-38 of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329077, which also lists 2 linked publications.
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 30 Nov 2023.