Clinical Data Collection for Obstetric Ultrasound Algorithms

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Caption Health, Inc.
Study ID
NCT06742229
Status
Not Yet Recruiting

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Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Research Ultrasound scan — DEVICE
    Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device

Study Details

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

Key Dates

Start date
Dec 20, 2024
Status verified
Dec 2024
Primary completion
Sep 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
700 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: 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
  • Other: 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

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Cresta Jones, MD
[email protected]
612-301-3408
Maria Bunch
[email protected]
Baylor College of MedicineHoustonTexas77030
Joan Mastrobattista, MD
[email protected]
281-491-6830

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