Clinical trial NCT06742229: Clinical Data Collection for Obstetric Ultrasound Algorithms
Official title: Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Obstetrics
Gynecology
Artificial Intelligence
Machine Learning
Lead sponsor: Caption Health, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups- Group 1 Pregnant and Group 2 Non Pregnant. From Group 1-Pregnant group we will obtain their standard of care scans along with the research scan whereas Non pregnant group will have only research scans
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to

* Collect ultrasound data from pregnant and non-pregnant individuals presenting to multiple study sites.
* Use the collected data and ultrasound images to train and validate Artificial intelligence algorithms developed by the Sponsor

Consented participants will be asked to take part in a research ultrasound scan

Detailed description: In this study pregnant and no pregnant subjects will be recruited from Obstetrics and Gynecology clinics/hospitals or from Maternal and Fetal Medicine centers. The pregnant subjects will be in Group 1 and non pregnant subjects will be in Group 2. Pregnant subjects are only recruited if they are scheduled for an obstetric standard of care scan . Both the group will undergo research scan, which is a sweep protocol using handheld FDA approved ultrasound device like Vscan. Patient chart history (no PHI), standard of care scan ultrasound images (no PHI), and research scan ultrasound images (no PHI) would be obtained from Group 1 subjects. Patient history (no PHI), research ultrasound images (no PHI) would be obtained from Group 2 subjects The data collected from this study will be used by the sponsor to develop algorithms for screening various fetal health parameters such as gestational age, placenta location, fetal heart rate, number of fetuses, fetal positions etc

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Eligibility criteria: Inclusion Criteria:

Pregnant group (Group 1)

1. Participants aged 18 years or older at time of consent.
2. Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
3. Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
4. Participants who provide written consent.

Non-pregnant group (Group 2)

1. Participants aged 18 years or older at time of consent.
2. Participants who are not actively pregnant (confirmed using an HCG urine test strip).
3. Participants who provide written informed consent.

Exclusion Criteria:

- 1. Participants for whom participating in this study would delay or compromise care in any way.

2. Participants who are not able to understand or provide written consent.

Primary outcomes:
measure: Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: