Pulsenmore ES Device, Efficacy and Safety Assessment

Not Applicable

Completed

• Conditions: Perinatal Care
• Interventions: Device: Pulsenmore ES home ultrasound device

• Registration Number: NCT05329077
• Lead Sponsor: PulseNmore

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-04-08
• Study Start: 2022-04-14
• Study First Posted: 2022-04-14
• Status Verified: 2023-03
• Primary Completion: 2023-06-09
• Study Completion: 2023-11-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home Ultrasound users	Pulsenmore ES home ultrasound device	Single Arm home ultrasound in pregnant women users

Primary Outcome Measures

Name	Time	Method
Comparison of device derived presence or absence of fetal cardiac activity to ground truth	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	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)

Secondary Outcome Measures

Name	Time	Method
Ability to detect fetal movement from device derived input will be compared to the ground truth	Test to be conducted during week 14-38 of pregnancy	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)
Ability to assess placental location from device derived input will be compared to the ground truth	Test to be conducted during week 14-38 of pregnancy	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)
Ability to detect fetal breathing from device derived input will be compared to the ground truth	Test to be conducted during week >27-38 of pregnancy	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)
Ability to assess fetal presentation from device derived input will be compared to the ground truth	Test to be conducted during week 14-38 of pregnancy	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)

Trial Locations

Locations (4)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Center for Fetal Medicine and Women's Ultrasound; 🇺🇸 Los Angeles, California, United States

Mount Sinai Hospital System; 🇺🇸 New York, New York, United States

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States