Status:
COMPLETED
Pulsenmore ES Device, Efficacy and Safety Assessment
Lead Sponsor:
PulseNmore
Conditions:
Perinatal Care
Eligibility:
FEMALE
18+ years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2023
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT05329077
Start Date
April 14 2022
End Date
November 11 2023
Last Update
November 30 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Fetal Medicine and Women's Ultrasound
Los Angeles, California, United States, 90048
2
University of Florida College of Medicine
Gainesville, Florida, United States, 32601-0294
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Mount Sinai Hospital System
New York, New York, United States, 10029