Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Kosmos Guidance Performance Evaluation Data Annotation

13 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

81

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Washington
      • Redmond, Washington, Stany Zjednoczone, 98052
        • EchoNous, Inc.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Guidance Algorithm Accuracy
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 sierpnia 2026

Ukończenie studiów (Szacowany)

30 września 2026

Daty rejestracji na studia

Pierwszy przesłany

13 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

18 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ECHO-302

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

Publication decisions will be made at a later date.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .