NCT06952439 - Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT | Biotech Hunter

Enrollment

551

Participants

Timeline

Start Date

March 19, 2025

Primary Completion Date

May 19, 2025

Study Completion Date

May 19, 2025

Conditions

To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant ParticipantsFirst Trimester Pregnancy

Interventions

DEVICE

Images and cines captured through the capture card (ICC)

A screen capture/recording of the entire exam performed by the ARDMS as per the Image Acquisition Protocol for the FDA Study will be obtained, and the images/cines required for the study that correspond to IUS shall be obtained. The independent research coordinator for the study will review the screen recording and identify the frame/cine for each diagnostic view (ICC) that corresponds to IUS based on the time stamps.

Trial Locations (15)

12180

Mobile Mama Ultrasound, LLC, Troy

27607

Mid-Carolina OB/GYN, Raleigh

70002

Sweet Pea 3D/4D Ultrasound Nola, New Orleans

73072

The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound, Norman

73106

The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound, Oklahoma City

74055

Tiny Blessings Ultrasound 4D Studio, Owasso

74070

Tiny Blessings Ultrasound 4D Studio, Skiatook

77018

Total Womens Care PLLC, Houston

77598

Reveal Ultrasound, LLC-S, Webster

92201

Harbinder S Brar MD Inc, Indio

92307

Harbinder S Brar MD Inc, Apple Valley

92374

Harbinder S Brar MD Inc, Redlands

92404

Harbinder S Brar MD Inc, San Bernardino

92506

Harbinder S Brar MD Inc, Riverside

92562

Harbinder S Brar MD Inc, Murrieta