Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Location contact
Ellen Grant, MD
PRINCIPAL_INVESTIGATOR
Fetal Imaging Research Team
CONTACT
NCT Number: NCT07676474
This study is a single-center, prospective, and non-randomized feasibility study designed to evaluate the practicality, tolerability, and data quality of short-duration continuous fetal monitoring using a wireless bioadhesive ultrasound device. The study involves a single visit per participant and does not include any therapeutic intervention.
Eligible participants will undergo placement of a wireless bioadhesive ultrasound (ABAUS) device on the maternal abdomen for a short-duration monitoring session. The device will acquire continuous or semi-continuous ultrasound data for a total of 10-30 minutes per participant, without altering standard clinical care. The study is observational and is intended to assess the technical feasibility of device placement, the stability of the coupling during routine maternal movement, image quality over time, and the ability to monitor fetal motion, heart rate, and uterine activity using the investigational device under controlled yet realistic clinical conditions.
The study is non-interventional. No diagnostic or therapeutic decisions will be made based on the ultrasound data collected as part of this research protocol, and all standard prenatal care will proceed independently of participation in this study.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Boston, Massachusetts, 02115, United States
Ellen Grant, MD
PRINCIPAL_INVESTIGATOR
Fetal Imaging Research Team
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo placement of the investigational wireless bio-adhesive ultrasound (ABAUS) device on the maternal abdomen. This device constitutes the sole study-related exposure. The device will be externally applied to intact abdominal skin using a skin-safe bio-adhesive and used to acquire continuous or semi-continuous ultrasound data for approximately 10-30 minutes.
Other names: wireless bioadhesive ultrasound (ABAUS).
Time frame: 10-30 minutes
Acquisition of fetal ultrasound imaging data over a 10-30 minute period
Time frame: 30 - 60 minutes
The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.
Contact information is provided by the study sponsor or research team.
Boston Children's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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