N/A
Completed N=8
GE CVUS Device Evaluation
Echocardiography
Source: ClinicalTrials.gov NCT05340244 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Number of User Feedback Surveys — 1 Completed User Survey
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of User Feedback Surveys |
1 | — |
| PRIMARY Number of De-identified Images |
329 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05340244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.