Trial Outcomes & Findings for Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation (NCT NCT02924129)
NCT ID: NCT02924129
Last Updated: 2024-01-03
Results Overview
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
3 months
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Evoke SCS With Feedback
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
|
Overall Study
COMPLETED
|
62
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Evoke SCS With Feedback
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Overall Study
Adverse Event Unrelated to Device or Stimulation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Missed Visit
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
Baseline characteristics by cohort
| Measure |
Evoke SCS With Feedback
n=67 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=67 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
67 participants
n=7 Participants
|
134 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention-to-Treat (ITT), which included randomized patients with either known endpoint status or classified as a presumed non-responder (i.e., \<50% reduction in overall pain at trial or withdrew due to a device- or stimulation-related adverse event), and therefore imputed as a failure.
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Outcome measures
| Measure |
Evoke SCS With Feedback
n=62 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=63 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Number of Participants With Composite Endpoint Success
|
51 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Outcome measures
| Measure |
Evoke SCS With Feedback
n=62 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=63 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Percent Change From Baseline in Leg Pain VAS Score
|
76.8 percentage change in VAS leg pain
Standard Deviation 28.3
|
67.8 percentage change in VAS leg pain
Standard Deviation 35.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Outcome measures
| Measure |
Evoke SCS With Feedback
n=62 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=63 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Percent Change From Baseline in Back Pain VAS Score
|
72.1 percentage change in VAS back pain
Standard Deviation 29.4
|
57.5 percentage change in VAS back pain
Standard Deviation 36.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Outcome measures
| Measure |
Evoke SCS With Feedback
n=62 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=63 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
|
36 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Outcome measures
| Measure |
Evoke SCS With Feedback
n=62 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=63 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
|
50 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat (ITT)
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Outcome measures
| Measure |
Evoke SCS With Feedback
n=59 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=59 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Number of Participants With Composite Endpoint Success
|
49 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Outcome measures
| Measure |
Evoke SCS With Feedback
n=59 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=59 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Percent Change From Baseline in Leg Pain VAS Score
|
72.9 percentage change in VAS leg pain
Standard Deviation 31.0
|
62.1 percentage change in VAS leg pain
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Outcome measures
| Measure |
Evoke SCS With Feedback
n=59 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=59 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Percent Change From Baseline in Back Pain VAS Score
|
69.4 percentage change in VAS back pain
Standard Deviation 30.6
|
54.0 percentage change in VAS back pain
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat (ITT)
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Outcome measures
| Measure |
Evoke SCS With Feedback
n=59 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=59 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
|
33 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Outcome measures
| Measure |
Evoke SCS With Feedback
n=59 Participants
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=59 Participants
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
|
47 Participants
|
34 Participants
|
Adverse Events
Evoke SCS With Feedback
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Evoke SCS With Conventional
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evoke SCS With Feedback
n=67 participants at risk
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=67 participants at risk
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Cardiac disorders
Arrhythmia and Irregularities
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Cardiac disorders
Cardiac Chest Pain
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Gastrointestinal disorders
Diverticulitis
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Infections and infestations
Epidural Abscess
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Musculoskeletal and connective tissue disorders
Facet Cyst
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Product Issues
Lead Breakage/Fracture
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Hepatobiliary disorders
Liver Abscess
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Psychiatric disorders
Suicidal Ideation or Attempt
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Vascular disorders
Transient Ischemic Attack
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Infections and infestations
Wound Infection
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
0.00%
0/67 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
Other adverse events
| Measure |
Evoke SCS With Feedback
n=67 participants at risk
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Evoke SCS With Conventional
n=67 participants at risk
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Symptoms or Upper Respiratory Tract Infection
|
10.4%
7/67 • Number of events 9 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
7.5%
5/67 • Number of events 5 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Injury, poisoning and procedural complications
Fall or Trip or Slip or Twist
|
4.5%
3/67 • Number of events 3 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
9.0%
6/67 • Number of events 7 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Product Issues
Lead Migration
|
6.0%
4/67 • Number of events 4 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
4.5%
3/67 • Number of events 3 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.5%
1/67 • Number of events 1 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
|
6.0%
4/67 • Number of events 5 • Through primary completion (3-months post-implant).
Serious adverse event is an AE that * Led to death * Led to serious deterioration in the health of the subject and either resulted in a: 1. life-threatening illness or injury or 2. permanent impairment of a body structure or a body function or 3. prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function * Led to fetal distress, fetal death or congenital anomaly or birth defect
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may not publish their site results until study completion and multicenter results are published, unless multicenter results are not submitted for publication within 12 months of study completion or they receive Sponsor authorization. PI must notify sponsor within 30 days of submitting their site results. Sponsor may require a delay of up to 90 days if determined patent applications need to be filed or confidential information removed.
- Publication restrictions are in place
Restriction type: OTHER