Trial Outcomes & Findings for ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP) (NCT NCT04319887)

NCT ID: NCT04319887

Last Updated: 2024-12-31

Results Overview

Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 12-months post-implant
• Results posted on: 2024-12-31

Participant Flow

Single-arm study. Subjects undergo a trial with the device, at which point they are enrolled, prior to receiving a permanent implant. Results are for implanted subjects.

Participant milestones

Measure	ECAP-controlled, Closed-loop SCS Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Overall Study STARTED	231
Overall Study COMPLETED	208
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

Baseline characteristics by cohort

Measure	ECAP-controlled, Closed-loop SCS n=231 Participants Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Age, Continuous	63.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	218 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	217 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	231 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-months post-implant

Population: patients who completed the 12-month follow-up visit

Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.

Outcome measures

Measure

ECAP-controlled, Closed-loop SCS n=208 Participants Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System

1.3 ratio Interval 1.1 to 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Visual Analogue Scale (VAS) to rate pain intensity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

10-item instrument that assesses Physical Health and Mental Health

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Single item measure of global improvement with treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Single item measure of satisfaction with treatment

Outcome measures

Outcome data not reported

Adverse Events

ECAP-controlled, Closed-loop SCS

Serious events: 38 serious events

Other events: 59 other events

Deaths: 3 deaths

Serious adverse events

Measure	ECAP-controlled, Closed-loop SCS n=300 participants at risk Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Injury, poisoning and procedural complications Fall or Trip or Slip or Twist	1.7% 5/300 • Number of events 5 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Pneumonia	1.0% 3/300 • Number of events 3 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Urinary Tract Infection	1.0% 3/300 • Number of events 3 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Cholelithiasis or Gallstones	0.67% 2/300 • Number of events 2 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Nervous system disorders Dural Puncture or Tear	0.67% 2/300 • Number of events 2 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Nervous system disorders Nerve Root or Spinal Cord Injury	0.67% 2/300 • Number of events 2 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Overdose	0.67% 2/300 • Number of events 2 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Septicemia	0.67% 2/300 • Number of events 2 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Abdominal Pain	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Activities of Daily Living (ADL) Injury	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Immune system disorders Allergic Reaction - Medications or Dressings	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Arthritis	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Immune system disorders Autoimmune, non-specific	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Bone Fracture	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Nervous system disorders Brain Hemorrhage	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Colitis	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Coronary Artery or Heart Disease	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Diarrhea	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Nervous system disorders Disorientation	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Immune system disorders Hematoma	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Hypoxia	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Endocrine disorders Inflammation	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Kidney Problems - Other	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 MRSA	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Myocardial Infarct or Heart Attack	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Immune system disorders Non-specific Infection	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Pulmonary Edema	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Respiratory Infection	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Spinal Stenosis	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Upper Respiratory Symptoms or Upper Respiratory Tract Infection	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.
Immune system disorders Wound Dehiscence	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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	0.33% 1/300 • Number of events 1 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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	ECAP-controlled, Closed-loop SCS n=300 participants at risk Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Evoke Spinal Cord Stimulation (SCS) System: A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Injury, poisoning and procedural complications Fall or Trip or Slip or Twist	12.3% 37/300 • Number of events 42 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Upper Respiratory Symptoms or Upper Respiratory Tract Infection	7.0% 21/300 • Number of events 25 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Activities of Daily Living (ADL) Injury	5.3% 16/300 • Number of events 17 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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 Arthritis	5.0% 15/300 • Number of events 15 • AE data were collected from consent through study completion/exit, an average of 1 year. SAE criteria: * Led to death, * Led to serious deterioration in the health of the subject, and that either resulted in: 1. a life-threatening illness or injury, or 2. a 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.

Additional Information

Angela Leitner

Saluda Medical

Phone: 651-208-4223

Email: angela.leitner@saludamedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI may publish their site's results if: * Multi-center results are published, unless authorized by Sponsor. If multi-center results are not submitted within 12 months of clinical trial conclusion, PI may publish their results; AND * Provide Sponsor 60 days to review. If Sponsor response not received within 60 days, PI may publish. If Sponsor determines the proposed publication contains confidential or patentable information, Sponsor may delay publication for up to 90 days from discovery.
• Publication restrictions are in place

Restriction type: OTHER