Pulsenmore ES Device, Efficacy and Safety Assessment

Perinatal Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329077
• Other study ID #: 2201V1
• Status: Completed
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: November 11, 2023

Study information

• Verified date: March 2023
• Source: PulseNmore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: November 11, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Perinatal Care

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Center for Fetal Medicine and Women's Ultrasound	Los Angeles	California
United States	Mount Sinai Hospital System	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
PulseNmore

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Guidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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