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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Fetal Imaging Research Team
- 电话号码：(617) 919-5088
- 邮箱：FetalImaging@childrens.harvard.edu
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Boston Children's Hospital
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首席研究员：
- Ellen Grant, MD
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接触：
- Fetal Imaging Research Team
- 电话号码：(617) 919-5088
- 邮箱：FetalImaging@childrens.harvard.edu
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Successful continuous abdominal imaging over a defined monitoring interval
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Ellen Grant, MD、Boston Children's Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB-P00054387
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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