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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Fetal Imaging Research Team
- Telefonnummer: (617) 919-5088
- E-mail: FetalImaging@childrens.harvard.edu
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Boston Children's Hospital
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Ledende efterforsker:
- Ellen Grant, MD
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Kontakt:
- Fetal Imaging Research Team
- Telefonnummer: (617) 919-5088
- E-mail: FetalImaging@childrens.harvard.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Singleton Pregnancy
Healthy persons pregnant with a single fetus.
All participants will be recruited through Boston Children's Hospital's Fetal Care and Surgery Center and must be receiving a fetal MRI as part of their clinical care.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Successful continuous abdominal imaging over a defined monitoring interval
Tidsramme: 10-30 minutes
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Acquisition of fetal ultrasound imaging data over a 10-30 minute period
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10-30 minutes
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Number of skin adverse events
Tidsramme: 30 - 60 minutes
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The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.
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30 - 60 minutes
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ellen Grant, MD, Boston Children's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IRB-P00054387
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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