An interventional study of Research Ultrasound scan in Pregnancy, sponsored by Caption Health, Inc.. Not yet recruiting at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Caption Health, Inc. · Not applicable, Interventional, and Other
The goal of this clinical trial is to
Consented participants will be asked to take part in a research ultrasound scan
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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Caption Health, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant group (Group 1)
Non-pregnant group (Group 2)
Exclusion Criteria:
This group is for pregnant subjects. They will have two ultrasound scans performed- One will be the standard of care ultrasound scan and the other will be research scan
Device: Research Ultrasound scan
This group is for non-pregnant subjects. They will have one ultrasound scan performed- it will be the research scan
Device: Research Ultrasound scan
Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device
Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history
All the participant's research ultrasound image will be obtained. This image will be checked for image quality on various stages of pregnancy as well as for non pregnant subjects. These images will be used to develop algorithms for measuring gestational age, placenta location etc.
Time frame: 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Caption Health, Inc.