Trial Outcomes & Findings for CoverEdge Algorithm Programming Study (NCT NCT02492880)
NCT ID: NCT02492880
Last Updated: 2022-11-04
Results Overview
Change in paresthesia distribution based on programming parameters
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
minimum 25 days post IPG implant
Results posted on
2022-11-04
Participant Flow
15 subjects were enrolled in the study. 1 subject was enrolled in error who did not meet all inclusion criteria and was withdrawn and 1 subject was lost to follow-up prior to completing the Programming Visit. Statistically relevant conclusions cannot be made from this small sample size.
Participant milestones
| Measure |
Precision Spectra™ SCS System Programming Features
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Precision Spectra™ SCS System Programming Features
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
CoverEdge Algorithm Programming Study
Baseline characteristics by cohort
| Measure |
Precision Spectra™ SCS System Programming Features
n=13 Participants
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: minimum 25 days post IPG implantChange in paresthesia distribution based on programming parameters
Outcome measures
| Measure |
Precision Spectra™ SCS System Programming Features
n=13 Participants
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
|
|---|---|
|
Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Yes
|
13 Participants
|
|
Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
No
|
0 Participants
|
Adverse Events
Precision Spectra™ SCS System Programming Features
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
Restriction type: LTE60