Clinical trial NCT05329077: Pulsenmore ES Device, Efficacy and Safety Assessment
Official title: A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Care
Lead sponsor: PulseNmore
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of device derived presence or absence of fetal cardiac activity to ground truth
timeFrame: Test to be conducted during week 14-38 of pregnancy
measure: Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth
timeFrame: Test to be conducted during week 14-38 of pregnancy
Secondary outcomes:
measure: Ability to assess fetal presentation from device derived input will be compared to the ground truth
timeFrame: Test to be conducted during week 14-38 of pregnancy
measure: Ability to assess placental location from device derived input will be compared to the ground truth
timeFrame: Test to be conducted during week 14-38 of pregnancy
measure: Ability to detect fetal movement from device derived input will be compared to the ground truth
timeFrame: Test to be conducted during week 14-38 of pregnancy
measure: Ability to detect fetal breathing from device derived input will be compared to the ground truth
timeFrame: Test to be conducted during week >27-38 of pregnancy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Fetal Medicine and Women's Ultrasound
state: California
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Hospital System
state: New York
Study officials:
affiliation: University of Florida
name: Reem Abu-Rustum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG)
citation: 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.