Pulsenmore ES Device, Efficacy and Safety Assessment

Study Overview
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Brief Summary
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This is a multicenter, prospective, investigational device study designed to evaluate: The safety, feasibility, and accuracy of the device, when used by pregnant individuals

Official Title
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A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women

Conditions
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Perinatal Care

Intervention / Treatment
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* Device: Pulsenmore ES home ultrasound device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Home Ultrasound users<br>Single Arm home ultrasound in pregnant women users | Device: Pulsenmore ES home ultrasound device<br>* Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Test to be conducted during week 14-38 of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | Test to be conducted during week >27-38 of pregnancy |