- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07771270
Kosmos Guidance Performance Evaluation Data Annotation
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Washington
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Redmond, Washington, Forente stater, 98052
- EchoNous, Inc.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Project 1
Participants included in Project 1, Category 1: Corrective Guidance
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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.
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Project 2
Participants included in Project 2, Category 2: Incorrect Scanning Window
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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.
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Project 3
Participants included in Project 3, Category 3: Incorrect Probe Orientation
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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.
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Project 4
Participants included in Project 4, Category 4: Low Confidence Prediction
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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.
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Project 5
Participants included in Project 5, Auto-Capture Frame-Level Re-annotation
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Guidance Algorithm Accuracy
Tidsramme: Post data acquisition (2 months)
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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.
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Post data acquisition (2 months)
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Performance of Auto-Capture
Tidsramme: Post data acquisition (2 months)
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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.
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Post data acquisition (2 months)
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ECHO-302
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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