Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Kosmos Guidance Performance Evaluation Data Annotation

13 augusti 2026 uppdaterad av: 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.

Studieöversikt

Studietyp

Observationell

Inskrivning (Beräknad)

81

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Washington
      • Redmond, Washington, Förenta staterna, 98052
        • EchoNous, Inc.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Guidance Algorithm Accuracy
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 juni 2026

Primärt slutförande (Beräknad)

30 augusti 2026

Avslutad studie (Beräknad)

30 september 2026

Studieregistreringsdatum

Först inskickad

13 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

13 augusti 2026

Första postat (Faktisk)

18 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ECHO-302

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Publication decisions will be made at a later date.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera