Trial Outcomes & Findings for Self Abrading Rapidly Applied Electrode Validation (NCT NCT02200523)
NCT ID: NCT02200523
Last Updated: 2020-08-13
Results Overview
The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
up to 1 hour
Results posted on
2020-08-13
Participant Flow
Participant milestones
| Measure |
SARA Electrode
new electrode
SARA electrode
|
Gold Cup
gold standard
Gold cup
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
anonymous data did not include specific age information
Baseline characteristics by cohort
| Measure |
SARA Electrode
n=20 Participants
new electrode
SARA electrode
|
Gold Cup
n=20 Participants
gold standard
Gold cup
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
anonymous data did not include gender information
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
anonymous data did not include gender information
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: up to 1 hourThe time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.
Outcome measures
| Measure |
SARA Electrode
n=20 Participants
new electrode
SARA electrode
|
Gold Cup
n=20 Participants
gold standard
Gold cup
|
|---|---|---|
|
Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode
|
30 seconds
Standard Deviation 10
|
45 seconds
Standard Deviation 10
|
Adverse Events
SARA Electrode
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gold Cup
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place