Pulsenmore ES Device, Efficacy and Safety Assessment

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