Pulsenmore ES Device, Efficacy and Safety Assessment

P

PulseNmore

Status

Completed

Conditions

Perinatal Care

Treatments

Device: Pulsenmore ES home ultrasound device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05329077
2201V1

Details and patient eligibility

About

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

Enrollment

188 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

188 participants in 1 patient group

Home Ultrasound users
Other group
Description:
Single Arm home ultrasound in pregnant women users
Treatment:
Device: Pulsenmore ES home ultrasound device

Trial contacts and locations

4

Loading...

Central trial contact

Tamar Sobol; Hagar Spits

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems