Trial Outcomes & Findings for Clinical Evaluation for General Electric (GE) CT System (NCT NCT01909180)

Results Overview

Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

24 hours

Results posted on

2016-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care Scan This is a single arm clinical trial. Standard of care scan Investigational Scan
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation for General Electric (GE) CT System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care Scan n=49 Participants This is a single arm clinical trial. Standard of care scan Investigational Scan
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	26 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Region of Enrollment United States	49 participants n=99 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: All cases were sufficient and had acceptable, good or excellent image quality

Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic

Outcome measures

Outcome measures
Measure	Cardiac n=57 Scan Images Subjects who received a cardiac CT scan	Body/ Extremity n=60 Scan Images Subject receiving a Revolution CT scan of the body or extremities	Neuro n=30 Scan Images Subjects receiving Revolution CT Scans of Brain or Spinal Cord
Image Quality	4.53 units on a scale Standard Deviation 0.68	4.44 units on a scale Standard Deviation 0.67	4.63 units on a scale Standard Deviation 0.61

Adverse Events

Standard of Care Scan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care Scan n=49 participants at risk This is a single arm clinical trial. Standard of care scan Investigational Scan
General disorders Vomitting	2.0% 1/49 • Number of events 1

Additional Information

RIchard Petrisko

GE Healthcare

Phone: 262-548-4637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place