Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

NCT06442358 | Completed FDA Device

• 1 other identifier: HUM00244136
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.

Conditions

Perinatal Care

Outcome Measures

Primary Outcomes (1)

• Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being

  Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level

  One day

Secondary Outcomes (2)

• Assess preliminary effectiveness and compare participant results to standard of care BPP

  One day

• Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.

  One day

Study Arms (1)

Single Arm home ultrasound in pregnant women require BPP

OTHER

Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician

Device: Pulsenmore ES home ultrasound device

Interventions

Pulsenmore ES home ultrasound device DEVICE

Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider

Single Arm home ultrasound in pregnant women require BPP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Singleton pregnancy
• Gestational age ≥ 24 0/7 weeks
• No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
• Ability to understand and sign informed consent in English
• Ability to read and understand instructions in English
• Ability to hold an ultrasound probe and respond to clinician instructions
• BMI less than 40 at initial prenatal visit
• Scheduled biophysical profile (BPP)
• Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.

You may not qualify if:

• Multiple gestation
• Known major fetal structural anomaly or aneuploidy
• Known fetal or genetic anomalies
• Ruptured membranes
• Uterine complaints, such as painful contractions
• Maternal concern for decreased fetal movement
• Not evaluated vaginal bleeding (not including spotting)
• Fetal or maternal criteria that require urgent delivery
• BMI ≥ 40 at initial prenatal visit

Sponsors & Collaborators

• PulseNmore: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Alex Peahl, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: April 10, 2024
• Primary Completion: September 9, 2024
• Study Completion: December 30, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)