Skip to main content
OpenTrials
Completed

NCT Number: NCT05329077

Pulsenmore ES Device, Efficacy and Safety Assessment

This is a multicenter, prospective, investigational device study designed to evaluate:

The safety, feasibility, and accuracy of the device, when used by pregnant individuals

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perinatal Care

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsenmore ES home ultrasound device

Device

Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters

Primary outcomes

  1. Comparison of device derived presence or absence of fetal cardiac activity to ground truth

    Time frame: 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)

  2. Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth

    Time frame: 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 outcomes

  1. Ability to assess fetal presentation from device derived input will be compared to the ground truth

    Time frame: 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)

  2. Ability to assess placental location from device derived input will be compared to the ground truth

    Time frame: 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)

  3. Ability to detect fetal movement from device derived input will be compared to the ground truth

    Time frame: 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)

  4. Ability to detect fetal breathing from device derived input will be compared to the ground truth

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

PulseNmore

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.