Trial Outcomes & Findings for GE CVUS Device Evaluation (NCT NCT05340244)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

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.

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Experimental n=8 Participants 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.
Age, Categorical <=18 years	7 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	4 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=8 Participants
Region of Enrollment United States	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1: Experimental n=8 Participants 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.
Number of User Feedback Surveys	1 Completed User Survey

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1: Experimental n=8 Participants 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.
Number of De-identified Images	329 Images Collected

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1: Experimental n=8 Participants 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.
Number of Safety Events	0 Adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1: Experimental n=8 Participants 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.
Number of Device Issues	0 device issues

Adverse Events

Arm 1: Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracy Grzendzielewski

GE Healthcare

Phone: 414-218-6167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place