Trial Outcomes & Findings for Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield) (NCT NCT02785588)

NCT ID: NCT02785588

Last Updated: 2019-09-13

Results Overview

Number of subject whose images were rated as Evaluable.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 1 Day
• Results posted on: 2019-09-13

Participant Flow

Participant milestones

Measure	3.0 T Neonatal MRI Scanner All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Phase 1: Initial Feasibility Assessment STARTED	49
Phase 1: Initial Feasibility Assessment COMPLETED	47
Phase 1: Initial Feasibility Assessment NOT COMPLETED	2
Phase2 Controlled Image &Data Collection STARTED	5
Phase2 Controlled Image &Data Collection COMPLETED	5
Phase2 Controlled Image &Data Collection NOT COMPLETED	0

Reasons for withdrawal

Measure	3.0 T Neonatal MRI Scanner All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Phase 1: Initial Feasibility Assessment Breakdown of investigational device	1
Phase 1: Initial Feasibility Assessment Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	3.0 T Neonatal MRI Scanner n=52 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Age, Categorical <=18 years	52 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=52 Participants
Age, Categorical >=65 years	0 Participants n=52 Participants
Sex: Female, Male Female	29 Participants n=52 Participants
Sex: Female, Male Male	23 Participants n=52 Participants
Region of Enrollment United Kingdom	52 participants n=52 Participants

PRIMARY outcome

Timeframe: 1 Day

Number of subject whose images were rated as Evaluable.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=47 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Image Diagnostic Quality for Phase 1	24 Participants

PRIMARY outcome

Timeframe: 1 Day

Safety will be assessed based on the number of Adverse Events in Phase 1.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=47 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Number of Participants Who Experienced an Adverse Event in Phase 1	1 Participants

PRIMARY outcome

Timeframe: 1 Day

Number of subject whose images were rated as Evaluable.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=5 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Image Diagnostic Quality for Phase 2	5 Participants

PRIMARY outcome

Timeframe: 1 Day

Safety will be assessed based on the number of Adverse Events in Phase 2.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=5 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Number of Participants Who Experienced an Adverse Event in Phase 2	0 Participants

SECONDARY outcome

Timeframe: 1 Day

Scores range from 1-Very Poor image quality to 5-Excellent image quality.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=47 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Summary of Image Quality and Assessment for Phase 1 Presence Artifact	3.02 score on a scale Standard Deviation 0.821
Summary of Image Quality and Assessment for Phase 1 Signal to noise ratio	3.72 score on a scale Standard Deviation 0.926
Summary of Image Quality and Assessment for Phase 1 Overall Quality	3.57 score on a scale Standard Deviation 0.773
Summary of Image Quality and Assessment for Phase 1 Image Contrast	3.85 score on a scale Standard Deviation 0.834
Summary of Image Quality and Assessment for Phase 1 Tissue Contrast	3.98 score on a scale Standard Deviation 0.766
Summary of Image Quality and Assessment for Phase 1 Fat/Water Homogeneity	3.64 score on a scale Standard Deviation 0.673

SECONDARY outcome

Timeframe: 1 Day

Scores range from 1-Very Poor image quality to 5-Excellent image quality.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=5 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Summary of Image Quality and Assessments for Phase 2 Overall Quality	4.2 score on a scale Standard Deviation 0.447
Summary of Image Quality and Assessments for Phase 2 Image Contrast	4.4 score on a scale Standard Deviation 0.548
Summary of Image Quality and Assessments for Phase 2 Presence Artifact	3.8 score on a scale Standard Deviation 0.447
Summary of Image Quality and Assessments for Phase 2 Signal to noise ratio	4 score on a scale Standard Deviation 0
Summary of Image Quality and Assessments for Phase 2 Tissue Contrast	4.2 score on a scale Standard Deviation 0.837
Summary of Image Quality and Assessments for Phase 2 Fat/Water Homogeneity	4 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 1 Day

Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.

Summary of means and standard deviations.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=52 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Per Subject Workflow and Transport Information Time in sponsor swaddle	66 minutes Standard Deviation 13.73
Per Subject Workflow and Transport Information Entire procedure time	66.33 minutes Standard Deviation 9.70
Per Subject Workflow and Transport Information MRI Scan time	35.15 minutes Standard Deviation 8.02

SECONDARY outcome

Timeframe: 1 Day

Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.

User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.

Question 1. I think that I would like to use this system frequently Question 2. I found the system unnecessarily complex Question 3. I thought the system was easy to use Question 4. I think that I would need support from a technician to be able to use this system Question 5. I found the various functions in this system were well integrated Question 6. I thought there was too much inconsistency in this system Question 7. I think that most people would learn to use this system very quickly Question 8. I found the system very cumbersome to use Question 9. I felt very confident using the system Question 10. I needed to learn a lot of things before I could get going with this system Question 11. I feel confident this system will meet my patient's needs Question 12. How likely is it that you would recommend this system to other professionals in your field?

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=52 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Overall Experience With the Neonatal MR Scanner Device Summary Question 1	4.13 score on a scale Standard Deviation 0.40
Overall Experience With the Neonatal MR Scanner Device Summary Question 2	1.77 score on a scale Standard Deviation 0.47
Overall Experience With the Neonatal MR Scanner Device Summary Question 3	4.25 score on a scale Standard Deviation 0.44
Overall Experience With the Neonatal MR Scanner Device Summary Question 4	1.90 score on a scale Standard Deviation 0.45
Overall Experience With the Neonatal MR Scanner Device Summary Question 5	4.02 score on a scale Standard Deviation 0.24
Overall Experience With the Neonatal MR Scanner Device Summary Question 6	2.17 score on a scale Standard Deviation 0.68
Overall Experience With the Neonatal MR Scanner Device Summary Question 7	4.20 score on a scale Standard Deviation 0.43
Overall Experience With the Neonatal MR Scanner Device Summary Question 8	1.73 score on a scale Standard Deviation 0.45
Overall Experience With the Neonatal MR Scanner Device Summary Question 9	4.12 score on a scale Standard Deviation 0.38
Overall Experience With the Neonatal MR Scanner Device Summary Question 10	1.88 score on a scale Standard Deviation 0.38
Overall Experience With the Neonatal MR Scanner Device Summary Question 11	4.06 score on a scale Standard Deviation 0.42
Overall Experience With the Neonatal MR Scanner Device Summary Question 12	4.15 score on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 1 Day

Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.

A measure of bi-polar items (opposite items), rated on a scale from 1 to 7. Closer to 1 indicates a measure closer to the first item and closer to 7 indicates a measure closer to the second item.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=52 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Bi-polar Product Description Scale Unfamiliar-Familiar	6.37 score on a scale Standard Deviation 0.63
Bi-polar Product Description Scale Easy-Difficult	1.53 score on a scale Standard Deviation 0.70
Bi-polar Product Description Scale Useful-Useless	1.61 score on a scale Standard Deviation 0.78
Bi-polar Product Description Scale Bad-Good	6.51 score on a scale Standard Deviation 0.70
Bi-polar Product Description Scale Routine-Unusual	1.65 score on a scale Standard Deviation 0.96
Bi-polar Product Description Scale Learnable-Not Learnable	1.25 score on a scale Standard Deviation 0.44
Bi-polar Product Description Scale Inefficient-Efficient	6.47 score on a scale Standard Deviation 0.50
Bi-polar Product Description Scale Resistant-Responsive	6.51 score on a scale Standard Deviation 0.61
Bi-polar Product Description Scale Annoying-Pleasing	6.22 score on a scale Standard Deviation 0.92
Bi-polar Product Description Scale Satisfying-Dissatisfying	1.92 score on a scale Standard Deviation 1.06
Bi-polar Product Description Scale Ineffective-Effective	6.25 score on a scale Standard Deviation 0.80
Bi-polar Product Description Scale Fast-Slow	1.57 score on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: 1 Day

Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.

Number and type of technical issues and device malfunctions

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=52 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Technical Issues and Malfunctions Device Malfunction	5 number of occurrences
Technical Issues and Malfunctions Technical Issues	0 number of occurrences

SECONDARY outcome

Timeframe: 1 Day

Population: There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.

Outcome measures

Measure	3.0 T Neonatal MRI Scanner n=52 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Subject Change in Temperature	0.17 Degrees Celsius Standard Deviation 0.23

Adverse Events

3.0 T Neonatal MRI Scanner

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	3.0 T Neonatal MRI Scanner n=54 participants at risk All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI scanner: eligible subjects will undergo neonatal MRI scan procedure
Cardiac disorders Bradycardia	1.9% 1/54 • Number of events 1 • 1 day

Additional Information

Yvonne Celestial

GE Healthcare

Phone: +33 130709133

Email: MarieYvonne.CELESTIAL@ge.com

Results disclosure agreements

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