Echocardiography
Conditions
Keywords
Transthoracic Echocardiography, Transesophageal Echocardiography
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInvestigational 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.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Has a clinical indication for a TEE and/or TTE procedure with an ultrasound device * Has a weight of at least 5kg * Are able and willing to comply with study procedures * If less than 7 years old, has a parent or legally authorized representative able and willing to provide written consent to participate * If 7-17 years old, are able and willing to provide written assent to participate AND have a parent or legally authorized representative able and willing to provide written consent to participate * If 18 years old or older, are able and willing to provide written consent to participate
Exclusion criteria
* Pregnant or suspected to be pregnant based on the opinion of a clinician investigator * Expected to be at increased risk due to study participation (e.g. due to sensitivities, relative or absolute contraindication to TEE), in the opinion of a clinician investigator * Previously participated in this study or are enrolled in another research study that could be expected to interfere with participation in study procedures * History of esophageal surgery or known vascular ring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of User Feedback Surveys | 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. | 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. |
| Number of De-identified Images | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Safety 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. | The number of adverse events will be reported. No clinical efficacy endpoints will be assessed. |
| Number of 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. | The number of device issues will be reported. No clinical efficacy endpoints will be assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Arm 1: Experimental | — |
|---|---|---|
| Age, Categorical <=18 years | 7 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Experimental | Number of De-identified Images | 329 Images Collected |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Experimental | Number of User Feedback Surveys | 1 Completed User Survey |
Other Pre-specified
Number of Device Issues
The number of device issues will be reported. No clinical efficacy endpoints will be assessed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Experimental | Number of Device Issues | 0 device issues |
Other Pre-specified
Number of Safety Events
The number of adverse events will be reported. No clinical efficacy endpoints will be assessed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Experimental | Number of Safety Events | 0 Adverse events |