Trial Outcomes & Findings for A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System (NCT NCT01076296)

NCT ID: NCT01076296

Last Updated: 2016-03-07

Results Overview

A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.

• Recruitment status: COMPLETED
• Target enrollment: 1000 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2016-03-07

Participant Flow

Participant milestones

Measure	Abnormal Left Ventricle Function Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.	Normal Left Ventricle Function Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.	Abnormal Right Ventricle Function Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.	Normal Right Ventricle Function Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.	Pulmonary Hypertension Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.	No Pulmonary Hypertension Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.	Heart Valve Disease Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.	No Heart Valve Disease Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
Overall Study STARTED	54	196	51	199	59	191	51	199
Overall Study COMPLETED	54	196	51	199	59	191	51	199
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System

Baseline characteristics by cohort

Measure	Total for All Groups Assessed n=1000 Participants Subjects assessed for LV function using both VScan and a clinical examination.
Age, Continuous	60.9 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	656 Participants n=5 Participants
Sex: Female, Male Male	344 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.

Outcome measures

Measure	Abnormal Left Ventricle Function n=54 Participants Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.	Normal Left Ventricle Function n=196 Participants Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.	Abnormal Right Ventricle Function n=51 Participants Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.	Normal Right Ventricle Function n=199 Participants Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.	Pulmonary Hypertension n=59 Participants Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.	No Pulmonary Hypertension n=191 Participants Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.	Heart Valve Disease n=51 Participants Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.	No Heart Valve Disease n=199 Participants Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
Percentage of Correct Diagnosis	61 percentage of correct diagnosis Interval 45.0 to 77.0	31 percentage of correct diagnosis Interval 23.0 to 39.0	47 percentage of correct diagnosis Interval 26.0 to 67.0	6 percentage of correct diagnosis Interval 1.0 to 12.0	10 percentage of correct diagnosis Interval 8.0 to 29.0	3 percentage of correct diagnosis Interval 3.0 to 9.0	39 percentage of correct diagnosis Interval 19.0 to 59.0	4 percentage of correct diagnosis Interval 2.0 to 9.0

Adverse Events

Abnormal Left Ventricle Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Left Ventricle Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Abnormal Right Ventricle Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Right Ventricle Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pulmonary Hypertension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Pulmonary Hypertension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heart Valve Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Heart Valve Disease

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

Anita Johnson

GE Healthcare

Phone: 262-548-2825

Email: Anita.Johnson@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60