Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Kosmos Guidance Performance Evaluation Data Annotation

13 de agosto de 2026 actualizado por: EchoNous Inc.
The purpose of this study is to supplement prior Kosmos Trio Guidance performance testing conducted under ECHO-020 Kosmos Guidance, Grading, and Capture Performance Evaluation Protocol. The Kosmos Trio Guidance algorithm is designed to provide guidance to help novice scanners acquire images and videos during ultrasound scanning of three cardiac views (Parastenal Long Axis, Apical 4 Chamber, and Apical 2 Chamber) with Kosmos Trio. The study will divide the guidance cues not evaluated sufficiently in the ECHO-020 study into four categories: 1) corrective guidance, 2) incorrect scanning window, 3) incorrect probe orientation, and 4) low confidence prediction. For each guidance cue evaluated in this study, expert annotators will review two clips: one suboptimal view, collected when the probe is positioned at an incorrect location; and one guided view, captured after the sonographer followed the probe motion cue displayed by the system. Annotators will review each pair of clips and respond indicating either i) Yes, the guided clip demonstrates the appropriate correction from the suboptimal view; ii) No, the guided clip does not demonstrate the appropriate correction from the suboptimal view; or iii) Unevaluable, the guided clip is technically inadequate for assessment. For each category of guidance cues, the outcome measure will be the rate at which annotators respond "Yes." Finally, this study will also evaluate the Kosmos Trio Auto-Capture algorithm's ability to detect and capture a diagnostic-quality image. Annotators will rate clips captured by Kosmos Trio Auto-Capture on an ACEP-based image quality scale. The outcome measure will be the image quality score. The study design involves the compilation of de-identified retrospective cardiac clips acquired using the Kosmos diagnostic ultrasound system. This data was collected for two previous studies; no additional data will be collected from previous study participants for the purposes of this study.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

81

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Washington
      • Redmond, Washington, Estados Unidos, 98052
        • EchoNous, Inc.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

The study used retrospective datasets from 2 sources: ECHO-020 Kosmos Guidance, Grading, and Capture Performance Evaluation study, and ECHO-025 Kosmos Guidance Performance Evaluation study. Both datasets comprise fully de-identified, retrospective, echocardiographic clips acquired using the Kosmos diagnostic ultrasound system.

Data collection for both studies was performed at EchoNous headquarters in Redmond, Washington. Source data was collected targeting a balanced representation of demographics and clinical characteristics (including gender and BMI) to ensure the generalizability of study findings.

Descripción

Inclusion Criteria:

  • All data used in this study must have been collected per 45 CFR § 26,
  • Data must have been collected per source protocol requirements with no deviation for that data set,
  • Adequate demographic information available from original study participation (sex, BMI, ethnicity, and race)
  • Exam acquisition performed by a qualified echocardiographer using the Kosmos system

Exclusion Criteria:

  • Inadequate demographic information corresponding to the available data, and
  • Non-echocardiographer acquired images.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Project 1
Participants included in Project 1, Category 1: Corrective Guidance
When the system detects that the probe is near the correct cardiac window but requires a specific directional adjustment, it displays a Category 1 - Corrective Guidance message. Each case in this project consists of two clips: Clip A - Suboptimal View: captured after the sonographer has intentionally moved the probe to a prescribed off-target position; and Clip B - Guided View: captured after the sonographer followed the Category 1 probe motion cue displayed by the system. For each pair of clips, annotators will be asked when Comparing Clip A and Clip B whether following the Category 1 corrective guidance instruction produces a discernible improvement in overall image quality. They will provide an answer of Yes, No, or Unevaluable.
Project 2
Participants included in Project 2, Category 2: Incorrect Scanning Window
When the system detects that the probe is positioned at a fundamentally incorrect anatomical location relative to the target cardiac view, it displays a Category 2 - Incorrect Scanning Window message. Each case in this project consists of two clips: Clip A - Suboptimal View: captured after the sonographer has intentionally a clearly incorrect anatomical location; and Clip B - Guided View: captured after the sonographer followed the Category 2 window-navigation cue and moved to the correct scanning window displayed by the system. For each pair of clips, annotators will be asked when Comparing Clip A and Clip B whether following the Category 2 guidance instruction produces a clip in the correct scanning window. They will provide an answer of Yes, No, or Unevaluable.
Project 3
Participants included in Project 3, Category 3: Incorrect Probe Orientation
When the system detects that the probe has been rotated 180° around its longitudinal axis, producing a laterally mirrored image, it displays a Category 3 - Incorrect Probe Orientation message. Each case in this project consists of two clips: Clip A - Suboptimal View: with the probe rotated 180° at the correct cardiac window, producing a mirrored image; and Clip B - Guided View: sonographer corrected the probe orientation in response to the Category 3 message displayed by the system. For each pair of clips, annotators will be asked when Comparing Clip A and Clip B whether following the Category 3 guidance instruction produced a clip that is oriented correctly. They will provide an answer of Yes, No, or Unevaluable.
Project 4
Participants included in Project 4, Category 4: Low Confidence Prediction
When the system's confidence in the current image is insufficient to issue a specific directional correction, it displays a Category 4 - Low Confidence Prediction message. Each case in this project consists of two clips: Clip A - Suboptimal View: with the probe rotated 180° at the correct cardiac window, producing a mirrored image; and Clip B - Guided View: sonographer corrected the probe orientation in response to the Category 3 message displayed by the system. For each pair of clips, annotators will be asked when Comparing Clip A and Clip B whether following the Category 3 guidance instruction produced a clip that is oriented correctly. They will provide an answer of Yes, No, or Unevaluable.
Project 5
Participants included in Project 5, Auto-Capture Frame-Level Re-annotation
The Kosmos Trio Auto-Capture feature automatically triggers clip recording when it detects that a diagnostic quality image has been achieved. Each case in this project is a single captured clip. No comparison clip is provided. The view (PLAX, A4C, or A2C) is indicated for each case. For each frame in this clip, annotators will be asked to assign a quality grade using the ACEP 1-5 image quality scale (where 1 represents a frame in which the relevant anatomy is not visualized or identifiable, and 5 represents a frame in which the image is sharp and the relevant anatomy is well visualized and present in the frame) to each frame.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Guidance Algorithm Accuracy
Periodo de tiempo: Post data acquisition (2 months)
Guidance algorithm accuracy will be evaluated using Positive Predictive Value (PPV), a calculation that compares the diagnostic quality between the suboptimal view following an indicated probe movement and the guided view following the Guidance correction of the probe location. PPV will be calculated for each cardiac view included in this study (PLAX, A4C, and A2C), across all four Guidance categories. PPV is calculated by dividing the number of True Positives (the number of trial pairs in which the post-action clip demonstrates that following the guidance instruction produced the intended improvement for the applicable guidance category) by the number of True Positives plus the number of False Positives (the number of trial pairs in which the post-action clip does not demonstrate the expected improvement for the applicable category). Success is defined as a PPV > 0.80 and 95% CI lower bound > 0.80 for each view. All three views must independently satisfy this criteria.
Post data acquisition (2 months)
Performance of Auto-Capture
Periodo de tiempo: Post data acquisition (2 months)
The accuracy of Auto-Capture will be evaluated using Positive Predictive Value (PPV), a calculation that provides the proportion of clips captured using Auto-Capture that contain a sufficient proportion of diagnostic-quality frames to be considered clinically acceptable. PPV is calculated by dividing the number of True Positives (the number of clips with at least one full cardiac cycle of frames is determined to be diagnostic by expert reviewers, in accordance with the ACEP-based grading scale) by the number of True Positives plus the number of False Positives (the number of clips that do not have at least one full cardiac cycle of frames is determined to be diagnostic by expert reviewers, in accordance with the ACEP-based grading scale). Success is defined as a PPV > 0.80 and 95% CI lower bound > 0.80.
Post data acquisition (2 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de junio de 2026

Finalización primaria (Estimado)

30 de agosto de 2026

Finalización del estudio (Estimado)

30 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

13 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de agosto de 2026

Publicado por primera vez (Actual)

18 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ECHO-302

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Publication decisions will be made at a later date.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir