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

NCT06952439 | Completed FDA Device

• 2 other identifiers: OMS-US-EA-FDA-CPA-0103/13/2025
• Study Type: observational
• Target: 551
• Locations: 1 country
• Sites: 15

Brief Summary

A multicenter study will be conducted to assess the role of the AI/ML technologies of Origin Medical EXAM ASSISTANT (OMEA) in interpreting first-trimester fetal ultrasound examinations (11 weeks 0 days - 13 weeks 6 days). The performance of the AI-based system will be compared against the ground truth provided by an independent reading panel of maternal-fetal medicine physicians.

Conditions

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

Keywords

Artificial Intelligence; Machine Learning; First Trimester Pregnancy; Ultrasound Imaging

Outcome Measures

Primary Outcomes (3)

• To assess whether the AI/ML technologies used in OMEA can achieve an acceptable sensitivity for identifying the diagnostic view

  The overall sensitivity and two-sided 95% confidence interval (CI) will be determined using data pooled across diagnostic views. Note: The participant is assessed for the primary outcome on the same day of enrollment.

  11 weeks 0 days to 13 weeks 6 days

• To assess whether the AI/ML technologies used in OMEA can achieve an acceptable sensitivity and consistency for verifying the quality criteria of a given image

  The overall sensitivity and two-sided 95% confidence interval (CI) will be determined using data pooled across diagnostic views for quality criteria. Note: The participant is assessed for the primary outcome on the same day of enrollment.

  11 weeks 0 days to 13 weeks 6 days

• To evaluate the performance of the OMEA AI/ML technologies with respect to facilitating the determination of quantitative measure of crown-rump length (CRL) and nuchal translucency (NT), complementary evaluations of agreement will be performed.

  The agreement and consistency of the AI/ML technologies used in OMEA to obtain quantitative measurements (i.e., CRL and NT) compared to the MFM physician average will be analyzed by applying Deming regression and Bland-Altman analysis. Note: The participant is assessed for the primary outcome on the same day of enrollment.

  11 weeks 0 days to 13 weeks 6 days

Secondary Outcomes (1)

• To assess the sensitivity and specificity for the detection of each of the individual diagnostic view of each of the individual quality criteria within each diagnostic view.

  11 weeks 0 days to 13 week 6 days

Other Outcomes (1)

• Evaluate the inter-observer agreement in the quantitative values of CRL and NT among the MFM physicians reading panel.

  11 weeks 0 days to 13 weeks 6 days

Study Arms (1)

Images and cines captured on the ultrasound machine (IUS)

American registered diagnostic medical sonographers (ARDMS; single operator/ultrasound scan room) shall conduct routine first-trimester scans as per the Image Acquisition Protocol for the FDA Study. Note: Patient exams that do not meet the study eligibility criteria, as identified or observed by the ARDMS, will be excluded at this stage. The exclusion criteria identified or observed by the sonographer are as follows: 1. Intrauterine fetal demise 2. Multiple gestations 3. Incorrect GA identified 4. Sonographer identifies structural abnormalities 5. Inability to continue the exam by the sonographer/patient Only the image frames and cine(s) from exams that satisfy the study inclusion criteria will be collected.

Device: Images and cines captured through the capture card (ICC)

Interventions

Images and cines captured through the capture card (ICC) DEVICE

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.

Images and cines captured on the ultrasound machine (IUS)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study involves first-trimester pregnant participants only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Origin Medical EXAM ASSISTANT™ is indicated for use during the first trimester (11 weeks 0 days to 13 weeks 6 days) fetal/obstetric ultrasound examinations of normal singleton pregnancies.

You may qualify if:

• Maternal age ≥ 18 years
• BMI \< 40 kg/m2
• Live non-anomalous singleton pregnancies
• Gestational age between 11 weeks + 0 days and 13 weeks + 6 days, as determined by:
• Last menstrual period (LMP) or, Ultrasound report if the the LMP date is uncertain Note: Gestational age determination follows standard American College of Obstetricians and Gynecologists (ACOG) guidelines.
• Informed consent is obtained from the participant
• Exams obtained as per the Image Acquisition Protocol

You may not qualify if:

• Multiple Pregnancies
• Cases with fetal demise or other fetal abnormalities observed/suspected after the ultrasound examination
• Cases of planned diagnostic ultrasound follow-up exams within 2 weeks for known or suspected abnormality after the current ultrasound examination for the study

Sponsors & Collaborators

• Origin Medical Systems, Inc.: lead

Study Sites (15)

Harbinder S Brar MD Inc

Apple Valley, California, 92307, United States

Location

Harbinder S Brar MD Inc

Indio, California, 92201, United States

Location

Harbinder S Brar MD Inc

Murrieta, California, 92562, United States

Location

Harbinder S Brar MD Inc

Redlands, California, 92374, United States

Location

Harbinder S Brar MD Inc

Riverside, California, 92506, United States

Location

Harbinder S Brar MD Inc

San Bernardino, California, 92404, United States

Location

Sweet Pea 3D/4D Ultrasound Nola

New Orleans, Louisiana, 70002, United States

Location

Mobile Mama Ultrasound, LLC

Troy, New York, 12180, United States

Location

Mid-Carolina OB/GYN

Raleigh, North Carolina, 27607, United States

Location

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

Norman, Oklahoma, 73072, United States

Location

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

Oklahoma City, Oklahoma, 73106, United States

Location

Tiny Blessings Ultrasound 4D Studio

Owasso, Oklahoma, 74055, United States

Location

Tiny Blessings Ultrasound 4D Studio

Skiatook, Oklahoma, 74070, United States

Location

Total Womens Care PLLC

Houston, Texas, 77018, United States

Location

Reveal Ultrasound, LLC-S

Webster, Texas, 77598, United States

Location

Related Publications (15)

• Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet. 1995 Oct 21;346(8982):1085-7. doi: 10.1016/s0140-6736(95)91748-9.

  PMID: 7564793 BACKGROUND

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

• Payne RB. Deming's regression analysis in method comparison studies. Ann Clin Biochem. 1985 Jul;22 ( Pt 4):430. doi: 10.1177/000456328502200419. No abstract available.

  PMID: 4037671 BACKGROUND

• Committee Opinion No 700: Methods for Estimating the Due Date. Obstet Gynecol. 2017 May;129(5):e150-e154. doi: 10.1097/AOG.0000000000002046.

  PMID: 28426621 BACKGROUND

• Ghelich Oghli M, Shabanzadeh A, Moradi S, Sirjani N, Gerami R, Ghaderi P, Sanei Taheri M, Shiri I, Arabi H, Zaidi H. Automatic fetal biometry prediction using a novel deep convolutional network architecture. Phys Med. 2021 Aug;88:127-137. doi: 10.1016/j.ejmp.2021.06.020. Epub 2021 Jul 6.

  PMID: 34242884 BACKGROUND

• Matthew J, Skelton E, Day TG, Zimmer VA, Gomez A, Wheeler G, Toussaint N, Liu T, Budd S, Lloyd K, Wright R, Deng S, Ghavami N, Sinclair M, Meng Q, Kainz B, Schnabel JA, Rueckert D, Razavi R, Simpson J, Hajnal J. Exploring a new paradigm for the fetal anomaly ultrasound scan: Artificial intelligence in real time. Prenat Diagn. 2022 Jan;42(1):49-59. doi: 10.1002/pd.6059. Epub 2021 Oct 18.

  PMID: 34648206 BACKGROUND

• Akkus Z, Cai J, Boonrod A, Zeinoddini A, Weston AD, Philbrick KA, Erickson BJ. A Survey of Deep-Learning Applications in Ultrasound: Artificial Intelligence-Powered Ultrasound for Improving Clinical Workflow. J Am Coll Radiol. 2019 Sep;16(9 Pt B):1318-1328. doi: 10.1016/j.jacr.2019.06.004.

  PMID: 31492410 BACKGROUND

• He F, Wang Y, Xiu Y, Zhang Y, Chen L. Artificial Intelligence in Prenatal Ultrasound Diagnosis. Front Med (Lausanne). 2021 Dec 16;8:729978. doi: 10.3389/fmed.2021.729978. eCollection 2021.

  PMID: 34977053 BACKGROUND

• Xiao S, Zhang J, Zhu Y, Zhang Z, Cao H, Xie M, Zhang L. Application and Progress of Artificial Intelligence in Fetal Ultrasound. J Clin Med. 2023 May 5;12(9):3298. doi: 10.3390/jcm12093298.

  PMID: 37176738 BACKGROUND

• Siddique J, Lauderdale DS, VanderWeele TJ, Lantos JD. Trends in prenatal ultrasound use in the United States: 1995 to 2006. Med Care. 2009 Nov;47(11):1129-35. doi: 10.1097/MLR.0b013e3181b58fbf.

  PMID: 19786915 BACKGROUND

• Kurjak A, Medjedovic E, Stanojevic M. Use and misuse of ultrasound in obstetrics with reference to developing countries. J Perinat Med. 2022 Oct 28;51(2):240-252. doi: 10.1515/jpm-2022-0438. Print 2023 Feb 23.

  PMID: 36302110 BACKGROUND

• Walsh CA, McAuliffe F, Kinsella V, McParland P. Routine obstetric ultrasound services. Ir Med J. 2013 Nov-Dec;106(10):311-3.

  PMID: 24579412 BACKGROUND

• Salomon LJ, Alfirevic Z, Bilardo CM, Chalouhi GE, Ghi T, Kagan KO, Lau TK, Papageorghiou AT, Raine-Fenning NJ, Stirnemann J, Suresh S, Tabor A, Timor-Tritsch IE, Toi A, Yeo G. ISUOG practice guidelines: performance of first-trimester fetal ultrasound scan. Ultrasound Obstet Gynecol. 2013 Jan;41(1):102-13. doi: 10.1002/uog.12342. No abstract available.

  PMID: 23280739 BACKGROUND

• International Society of Ultrasound in Obstetrics and Gynecology; Bilardo CM, Chaoui R, Hyett JA, Kagan KO, Karim JN, Papageorghiou AT, Poon LC, Salomon LJ, Syngelaki A, Nicolaides KH. ISUOG Practice Guidelines (updated): performance of 11-14-week ultrasound scan. Ultrasound Obstet Gynecol. 2023 Jan;61(1):127-143. doi: 10.1002/uog.26106. No abstract available.

  PMID: 36594739 BACKGROUND

• AIUM Practice Parameter for the Performance of Standard Diagnostic Obstetric Ultrasound. J Ultrasound Med. 2024 Jun;43(6):E20-E32. doi: 10.1002/jum.16406. Epub 2024 Jan 15. No abstract available.

  PMID: 38224490 BACKGROUND

Related Links

• The Sustainable Development Goals (SDGs; Goal 3) and the United Nations Global Strategy for Women's, Children's, and Adolescents' Health targeting reduction in the global maternal mortality ratio.
• The Sustainable Development Goals (SDGs; Goal 3) and the United Nations Global Strategy for Women's, Children's, and Adolescents' Health targeting reduction in the global maternal mortality ratio.

Study Officials

• Jeroen Peter Vanderhoeven, MD

  Providence Swedish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 30, 2025
• Study Start: March 19, 2025
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)