NCT07590063尚未招募不适用
Technology Development of Diagnostic Ultrasound System for Obstetric Imaging
United Imaging Healthcare North America, Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Pregnant persons age 18-45 years
- •Single intrauterine pregnancy
- •Gestational duration: 18 - 28 weeks
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.).
- •Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention.
- •Pregnant individuals with a medical or surgical history that may impact quality of ultrasound imaging:
- •Body Mass Index (BMI) > 40
- •Prior surgeries including: abdominal mesh placement; abdominoplasty
- •Vaginal bleeding within the last 6 weeks
- •Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma.
- •Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids
- •Non-English speaking.
- •Participants deemed unsuitable by the investigator due to safety or data integrity.
研究者
研究点 (1)
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