Clinical Data Collection for Obstetric Ultrasound Algorithms

N/ANot Yet RecruitingNCT06742229

Caption Health, Inc.700 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

700

Conditions

Pregnancy

Interventions

Research Ultrasound scanDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

University of Minnesota

Minneapolis, Minnesota, United States

Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Central Contacts

Reshma Rajan-Joy, PhD

CONTACT

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

Yngvil Thomas

CONTACT

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

Data from ClinicalTrials.gov

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