Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
NCT06442358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-06-24
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
Interventions
- DEVICE
-
Pulsenmore ES home ultrasound 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
Sponsors & Collaborators
- collaborator OTHER
-
PulseNmore
lead INDUSTRY
Principal Investigators
-
Alex Peahl, MD · University of Michigan
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-10
- Primary Completion
- 2024-09-09
- Completion
- 2024-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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