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Clinical Data Collection for Obstetric Ultrasound Algorithms

NCT ID: NCT06742229

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-12-30

Brief Summary

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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

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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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Conditions

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Pregnancy

Keywords

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Obstetrics Gynecology Artificial Intelligence Machine Learning

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1: Pregnant Subjects

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

Group Type OTHER

Research Ultrasound scan

Intervention Type DEVICE

Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Group 2- Non pregnant Subjects

This group is for non-pregnant subjects. They will have one ultrasound scan performed- it will be the research scan

Group Type OTHER

Research Ultrasound scan

Intervention Type DEVICE

Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Interventions

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Research Ultrasound scan

Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Caption Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Reshma Rajan-Joy, PhD

Role: CONTACT

Phone: 445-221-3076

Email: [email protected]

Yngvil Thomas

Role: CONTACT

Phone: 312-316-5632

Email: [email protected]

Facility Contacts

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Cresta Jones, MD

Role: primary

Maria Bunch

Role: backup

Joan Mastrobattista, MD

Role: primary

Other Identifiers

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CAP-MOBUS-24-02

Identifier Type: -

Identifier Source: org_study_id