EVOKE: Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Evoke SCS with Feedback closed-loop/automatic stimulation |
Device: Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
| Active Comparator: Evoke SCS with Conventional open-loop/manual stimulation |
Device: Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Composite Endpoint Success [3 months]
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.
Secondary Outcome Measures
- Change From Baseline in Overall Trunk and Limb VAS Pain Score [3 and 12 months]
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
- Change From Baseline in Back VAS Pain Score [3 and 12 months]
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
- Change From Baseline in Leg VAS Pain Score [3 and 12 months]
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is male or female between the ages of 18 and 80 years.
-
Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
-
Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
-
Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
Exclusion Criteria:
-
Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
-
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
-
Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
-
Have prior experience with SCS.
-
Have an active systemic infection or local infection in the area of the surgical site.
-
Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
-
Be concomitantly participating in another clinical study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thrive Clinic | Santa Rosa | California | United States | 95403 |
Sponsors and Collaborators
- Saluda Medical Americas, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- SCLSH1503
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Evoke SCS With Feedback | Evoke SCS With Conventional |
|---|---|---|
| Arm/Group Description | closed-loop/automatic stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | open-loop/manual stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). |
| Period Title: Overall Study | ||
| STARTED | 67 | 67 |
| COMPLETED | 62 | 63 |
| NOT COMPLETED | 5 | 4 |
Baseline Characteristics
| Arm/Group Title | Evoke SCS With Feedback | Evoke SCS With Conventional | Total |
|---|---|---|---|
| Arm/Group Description | closed-loop/automatic stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | open-loop/manual stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | Total of all reporting groups |
| Overall Participants | 67 | 67 | 134 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54.6
(9.7)
|
55.9
(11.6)
|
55.2
(10.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
33
49.3%
|
32
47.8%
|
65
48.5%
|
| Male |
34
50.7%
|
35
52.2%
|
69
51.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
4.5%
|
6
9%
|
9
6.7%
|
| Not Hispanic or Latino |
64
95.5%
|
61
91%
|
125
93.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
1.5%
|
2
3%
|
3
2.2%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
3%
|
6
9%
|
8
6%
|
| White |
63
94%
|
59
88.1%
|
122
91%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
1.5%
|
0
0%
|
1
0.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
67
100%
|
67
100%
|
134
100%
|
Outcome Measures
| Title | Number of Participants With Composite Endpoint Success |
|---|---|
| Description | 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. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Evoke SCS With Feedback | Evoke SCS With Conventional |
|---|---|---|
| Arm/Group Description | closed-loop/automatic stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | open-loop/manual stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). |
| Measure Participants | 62 | 63 |
| Count of Participants [Participants] |
51
76.1%
|
38
56.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Evoke SCS With Feedback, Evoke SCS With Conventional |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | non-inferiority margin (δ) of 10% | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Significance threshold (α) of 0.05 | |
| Method | normal approximation to the binomial | |
| Comments | ||
| Title | Change From Baseline in Overall Trunk and Limb VAS Pain Score |
|---|---|
| Description | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
| Time Frame | 3 and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Back VAS Pain Score |
|---|---|
| Description | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
| Time Frame | 3 and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Leg VAS Pain Score |
|---|---|
| Description | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
| Time Frame | 3 and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Through primary completion (3-months post-implant). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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: life-threatening illness or injury or permanent impairment of a body structure or a body function or prolonged hospitalization or 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 | |||
| Arm/Group Title | Evoke SCS With Feedback | Evoke SCS With Conventional | ||
| Arm/Group Description | closed-loop/automatic stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | open-loop/manual stimulation Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | ||
All Cause Mortality |
||||
| Evoke SCS With Feedback | Evoke SCS With Conventional | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/67 (0%) | 0/67 (0%) | ||
Serious Adverse Events |
||||
| Evoke SCS With Feedback | Evoke SCS With Conventional | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/67 (10.4%) | 4/67 (6%) | ||
| Cardiac disorders | ||||
| Arrhythmia and Irregularities | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
| Cardiac Chest Pain | 0/67 (0%) | 0 | 1/67 (1.5%) | 1 |
| Gastrointestinal disorders | ||||
| Diverticulitis | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Liver Abscess | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
| Infections and infestations | ||||
| Cellulitis | 1/67 (1.5%) | 1 | 1/67 (1.5%) | 1 |
| Epidural Abscess | 0/67 (0%) | 0 | 1/67 (1.5%) | 1 |
| Wound Infection | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Facet Cyst | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
| Product Issues | ||||
| Lead Breakage/Fracture | 0/67 (0%) | 0 | 1/67 (1.5%) | 1 |
| Psychiatric disorders | ||||
| Suicidal Ideation or Attempt | 0/67 (0%) | 0 | 1/67 (1.5%) | 1 |
| Renal and urinary disorders | ||||
| Renal Insufficiency | 0/67 (0%) | 0 | 1/67 (1.5%) | 1 |
| Vascular disorders | ||||
| Transient Ischemic Attack | 1/67 (1.5%) | 1 | 0/67 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Evoke SCS With Feedback | Evoke SCS With Conventional | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/67 (20.9%) | 15/67 (22.4%) | ||
| Infections and infestations | ||||
| Upper Respiratory Symptoms or Upper Respiratory Tract Infection | 7/67 (10.4%) | 9 | 5/67 (7.5%) | 5 |
| Injury, poisoning and procedural complications | ||||
| Fall or Trip or Slip or Twist | 3/67 (4.5%) | 3 | 6/67 (9%) | 7 |
| Product Issues | ||||
| Lead Migration | 4/67 (6%) | 4 | 3/67 (4.5%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchitis | 1/67 (1.5%) | 1 | 4/67 (6%) | 5 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Angela Leitner |
|---|---|
| Organization | Saluda Medical |
| Phone | 651-208-4223 |
| angela.leitner@saludamedical.com |
- SCLSH1503