PregnancyMOBUSNCT06742229
Clinical Data Collection for Obstetric Ultrasound Algorithms
A study testing Research Ultrasound scan in people with Pregnancy, run by Caption Health, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Research Ultrasound scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Dec 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant group (Group 1)
- Participants aged 18 years or older at time of consent.
- Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
- Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
- Participants who provide written consent.
- Non-pregnant group (Group 2)
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- Participants aged 18 years or older at time of consent.
- Participants who are not actively pregnant (confirmed using an HCG urine test strip).
- Participants who provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Baylor College of Medicine
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms
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
Read the 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
Th
- Conditions
- Pregnancy
- Being tested
- Research Ultrasound scan
- Keywords
- Obstetrics, Gynecology, Artificial Intelligence, Machine Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research Ultrasound scanDevice
Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pregnant Subjects | Other | 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 Receives: Device: Research Ultrasound scan |
| Group 2- Non pregnant Subjects | Other | This group is for non-pregnant subjects. They will have one ultrasound scan performed- it will be the research scan Receives: Device: Research Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start20 Dec 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Why it stopped: Study paused temporarily pending IRB approval of an amendment to the protocol and consent form.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caption Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742229
- Sponsor's protocol ID
- CAP-MOBUS-24-02
- Acronym
- MOBUS
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms
- ClinicalTrials.gov ID
- NCT06742229
- Acronym / sponsor ID
- MOBUS / CAP-MOBUS-24-02
- Conditions
- Pregnancy
- Keywords
- Obstetrics, Gynecology, Artificial Intelligence, Machine Learning
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study paused temporarily pending IRB approval of an amendment to the protocol and consent form.
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Caption Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Th
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pregnant Subjects | Other | Device: Research Ultrasound scanThis 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 |
| Group 2- Non pregnant Subjects | Other | Device: Research Ultrasound scanThis group is for non-pregnant subjects. They will have one ultrasound scan performed- it will be the research scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pregnant group (Group 1)
- Participants aged 18 years or older at time of consent.
- Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
- Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
- Participants who provide written consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research Ultrasound scanBoth the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device | Device | Group 1: Pregnant Subjects, Group 2- Non pregnant Subjects |
Primary outcome
Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history
Time frame: 9 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research Ultrasound scan in people with Pregnancy, run by Caption Health, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.