Status:
COMPLETED
GE CVUS Device Evaluation
Lead Sponsor:
GE Healthcare
Conditions:
Echocardiography
Eligibility:
All Genders
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05340244
Start Date
June 1 2022
End Date
July 26 2022
Last Update
January 10 2023
Active Locations (1)
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1
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108