Pulsenmore ES Device, Efficacy and Safety Assessment

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

Study Overview

• Status: Completed
• Conditions: Perinatal Care
• Intervention / Treatment: Device: Pulsenmore ES home ultrasound device

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamar Sobol; Phone Number: 914-721-0615; Email: tamar@pulsenmore.com
• Study Contact Backup: Name: Hagar Spits; Email: hagar@pulsenmore.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Center for Fetal Medicine and Women's Ultrasound
  • Florida
    • Gainesville, Florida, United States, 32601-0294
      • University of Florida College of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PulseNmore
• Investigators: Principal Investigator: Reem Abu-Rustum, MD, University of Florida

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2201V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No