Pulsenmore ES Device, Efficacy and Safety Assessment

Completed · Not applicable

Conditions studied: Perinatal Care

In brief

This is a multicenter, prospective, investigational device study designed to evaluate: The safety, feasibility, and accuracy of the device, when used by pregnant individuals

Key facts

Study ID

NCT05329077

Run by

PulseNmore

People needed

188

Starts

2022-04-14

Expected to finish

2023-11-11

Last updated by the study team

2023-11-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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