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The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device.
The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device. The primary objective of this study is to collect user feedback and de-identified images from the Vivid E95 ultrasound system and probes in TTE and TEE exams in a clinical setting. User feedback will include workflow, performance, user preference, image quality, device features, and open-ended feedback. The safety objective of this study is to collect safety information, including type and number of adverse events and device issues.
This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States. This study is not intended to support a comparative claim or test any hypotheses, such as superiority or non-inferiority. No clinical efficacy endpoints will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational ultrasound exam | Device | Eligible subjects will be enrolled into the study and positioned for their ultrasound exam. Standard clinical practice procedures will be followed using the standard of care device at the site to complete the clinically indicated exams. After the clinically indicated exam, portions of the TTE and/or TEE exam will be repeated with the investigational ultrasound device. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of User Feedback Surveys | The primary objective of this study is to collect user feedback from the investigational ultrasound system in TTE and TEE exams in a clinical setting. User Surveys consist of Likert scales and qualitative feedback and this data will not follow a statistical analysis plan. | The total number of User Surveys will be reported. Surveys capture feedback from the device user across multiple subjects. The protocol did not require surveys be collected at specific timepoints. The device was used on each subject for about 15 minutes. |
| Number of De-identified Images | The primary objective of this study is to collect de-identified images from the investigational ultrasound system in TTE and TEE exams in a clinical setting. | The total number of images collected will be reported. Multiple images are collected from each subject and the protocol does not require images to be collected at specific points in time. The device was used on each subject for about 15 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety Events | The number of adverse events will be reported. No clinical efficacy endpoints will be assessed. | The total number of adverse events will be reported. Subjects were monitored for adverse events throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes per subject. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Experimental | Investigational ultrasound exam: Eligible subjects will be enrolled into the study and positioned for their ultrasound exam. Standard clinical practice procedures will be followed using the standard of care device at the site to complete the clinically indicated exams. After the clinically indicated exam, portions of the TTE and/or TEE exam will be repeated with the investigational ultrasound device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Experimental | Investigational ultrasound exam: Eligible subjects will be enrolled into the study and positioned for their ultrasound exam. Standard clinical practice procedures will be followed using the standard of care device at the site to complete the clinically indicated exams. After the clinically indicated exam, portions of the TTE and/or TEE exam will be repeated with the investigational ultrasound device. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of User Feedback Surveys | The primary objective of this study is to collect user feedback from the investigational ultrasound system in TTE and TEE exams in a clinical setting. User Surveys consist of Likert scales and qualitative feedback and this data will not follow a statistical analysis plan. | Posted | Number | Completed User Survey | The total number of User Surveys will be reported. Surveys capture feedback from the device user across multiple subjects. The protocol did not require surveys be collected at specific timepoints. The device was used on each subject for about 15 minutes. |
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The subjects were monitored for adverse events throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes.
As per the study protocol, this study employed the Adverse Event (AE) and Serious Adverse Event (SAE) definitions of ISO14155:2020.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Experimental | Investigational ultrasound exam: Eligible subjects will be enrolled into the study and positioned for their ultrasound exam. Standard clinical practice procedures will be followed using the standard of care device at the site to complete the clinically indicated exams. After the clinically indicated exam, portions of the TTE and/or TEE exam will be repeated with the investigational ultrasound device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Grzendzielewski | GE Healthcare | 414-218-6167 | tracy.grzendzielewski@ge.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2022 | Sep 15, 2022 | Prot_000.pdf |
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This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
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| Number of Device Issues |
The number of device issues will be reported. No clinical efficacy endpoints will be assessed. |
| The total number of device issues will be reported. Study staff monitored for device issues throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes per subject. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of De-identified Images | The primary objective of this study is to collect de-identified images from the investigational ultrasound system in TTE and TEE exams in a clinical setting. | Posted | Number | Images Collected | The total number of images collected will be reported. Multiple images are collected from each subject and the protocol does not require images to be collected at specific points in time. The device was used on each subject for about 15 minutes. |
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| Other Pre-specified | Number of Safety Events | The number of adverse events will be reported. No clinical efficacy endpoints will be assessed. | Posted | Number | Adverse events | The total number of adverse events will be reported. Subjects were monitored for adverse events throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes per subject. |
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| Other Pre-specified | Number of Device Issues | The number of device issues will be reported. No clinical efficacy endpoints will be assessed. | Posted | Number | device issues | The total number of device issues will be reported. Study staff monitored for device issues throughout the duration (start to conclusion) of each investigational ultrasound exam, an average of 15 minutes per subject. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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