N/A
Completed N=1,000
A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
Source: ClinicalTrials.gov NCT01076296 ↗Enrolled (actual)
1,000
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Correct Diagnosis — 61; 31; 47; 6 percentage of correct diagnosis
Summary
This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Correct Diagnosis |
61; 31; 47; 6; 10; 3 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study
- New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care
Exclusion Criteria
- Pregnant
- less than 18 years of age.
- unwilling to provide informed Consent
Data sourced from ClinicalTrials.gov (NCT01076296). 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.