Clinical Data Collection for Obstetric Ultrasound Algorithms

NCT06742229 | Not Yet Recruiting FDA Device

• 1 other identifier: CAP-MOBUS-24-02
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 2

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

Conditions

Pregnancy

Keywords

Obstetrics; Gynecology; Artificial Intelligence; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Study Arms (2)

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

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

Device: Research Ultrasound scan

Interventions

Research Ultrasound scan DEVICE

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

Group 1: Pregnant Subjects; Group 2- Non pregnant Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• \- 1. Participants for whom participating in this study would delay or compromise care in any way.
• \. Participants who are not able to understand or provide written consent.

Sponsors & Collaborators

• Caption Health, Inc.: lead

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Central Study Contacts

Reshma Rajan-Joy, PhD

CONTACT

445-221-3076; reshma.rajan-joy@gehealthcare.com

Yngvil Thomas

CONTACT

312-316-5632; yngvil.thomas@gehealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 19, 2024
• Study Start: December 20, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)