Pulsenmore ES Device, Efficacy and Safety Assessment

Last updated: November 28, 2023
Sponsor: PulseNmore
Overall Status: Completed

Phase

N/A

Condition

Labor/delivery

Treatment

Pulsenmore ES home ultrasound device

Clinical Study ID

NCT05329077
2201V1
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • Singleton gestation.
  • Gestational age >14 weeks with a prior scan demonstrating fetal viability andconfirming dates.
  • English or Spanish speaking.
  • Ability to understand and sign the informed consent (available in English andSpanish).
  • Ability to read and understand instructions that are required for equipment use (instructions available in both languages).

Exclusion

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 Design

Total Participants: 188
Treatment Group(s): 1
Primary Treatment: Pulsenmore ES home ultrasound device
Phase:
Study Start date:
April 14, 2022
Estimated Completion Date:
November 11, 2023

Connect with a study center

  • Center for Fetal Medicine and Women's Ultrasound

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of Florida College of Medicine

    Gainesville, Florida 32601-0294
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Mount Sinai Hospital System

    New York, New York 10029
    United States

    Site Not Available

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