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NCT Number: NCT07676474

Continuous Wireless Ultrasound to Monitor Fetal Health

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location contact

Ellen Grant, MD

PRINCIPAL_INVESTIGATOR

Fetal Imaging Research Team

CONTACT

[email protected]

(617) 919-5088

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant individual 18 years or older
  • Singleton uterine pregnancy
  • Gestational age 20 to 39 gestational weeks
  • Able to provide written informed consent
  • Willing to go an single visit lasting 45 minutes - 1 hour including device placement, monitoring and removal
  • Willing to permit placement of the wireless bioadhesive ultrasound device on their abdomen for approximately 10-30 minutes

Exclusion criteria

  • Multiple gestation
  • Maternal abdominal skin condition at the potential site of attachment, such as rash, open wound, etc., preventing placement
  • Known allergy or hypersensitivity to adhesive material or hydrogel products
  • Need for urgent clinical management/triage
  • BMI > 35, as the signal quality could be impacted by BMI and not the device specifically

Treatment and study plan

Wireless Ultrasound Device

Device

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).

Primary outcomes

  1. Successful continuous abdominal imaging over a defined monitoring interval

    Time frame: 10-30 minutes

    Acquisition of fetal ultrasound imaging data over a 10-30 minute period

  2. Number of skin adverse events

    Time frame: 30 - 60 minutes

    The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Fetal Imaging Research Team

CONTACT

[email protected]

(617) 919-5088

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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