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Kosmos Guidance Performance Evaluation Data Annotation

2026년 8월 13일 업데이트: 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.

연구 개요

연구 유형

관찰

등록 (추정된)

81

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Washington
      • Redmond, Washington, 미국, 98052
        • EchoNous, Inc.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Guidance Algorithm Accuracy
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 5일

기본 완료 (추정된)

2026년 8월 30일

연구 완료 (추정된)

2026년 9월 30일

연구 등록 날짜

최초 제출

2026년 8월 13일

QC 기준을 충족하는 최초 제출

2026년 8월 13일

처음 게시됨 (실제)

2026년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 13일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ECHO-302

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Publication decisions will be made at a later date.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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