Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evoke SCS with Feedback | Experimental | closed-loop/automatic stimulation |
|
| Evoke SCS with Conventional | Active Comparator | open-loop/manual stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoke Spinal Cord Stimulator (SCS) System | Device | Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite Endpoint Success | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Leg Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 3 months |
| Percent Change From Baseline in Back Pain VAS Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dan Brounstein, MBA | Saluda Medical Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85027 | United States | ||
| Arizona Pain Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37640452 | Derived | Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751. | |
| 37491149 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Evoke SCS With Conventional |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2018 | Mar 29, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
| 3 months |
| Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | 3 months |
| Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 3 months |
| Number of Participants With Composite Endpoint Success | 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. | 12 months |
| Percent Change From Baseline in Leg Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months |
| Percent Change From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months |
| Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months |
| Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | 12 months |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Summit Pain Alliance | Santa Rosa | California | 95401 | United States |
| Thrive Clinic | Santa Rosa | California | 95403 | United States |
| IPM Medical Group | Walnut Creek | California | 94598 | United States |
| Pain Management Associates | Lee's Summit | Missouri | 64086 | United States |
| Premier Pain Centers | Shrewsbury | New Jersey | 07702 | United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Integrated Pain Solutions | Columbus | Ohio | 43240 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Delaware Valley Pain & Spine Institute | Feasterville-Trevose | Pennsylvania | 19053 | United States |
| Center for Pain Relief | Charleston | West Virginia | 25301 | United States |
| Advanced Pain Management | Greenfield | Wisconsin | 53221 | United States |
| Derived |
| Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, Hunter CW, Poree L, Staats PS, Taylor RS, Eldabe S, Kallewaard JW, Thomson S, Petersen EA, Sayed D, Deer TR, Antony A, Budwany R, Leitner A, Soliday N, Duarte RV, Levy RM. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. 2024 Apr 2;49(4):233-240. doi: 10.1136/rapm-2023-104639. |
| 36437161 | Derived | Costandi S, Kapural L, Mekhail NA, Jotwani R, Bertisch SM, Li S, Petersen E, Abejon D, Poree L, Ouyang Z, Venkatesan L, Mekhail MN, Gilligan CJ. Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis. Neuromodulation. 2023 Jul;26(5):1030-1038. doi: 10.1016/j.neurom.2022.10.050. Epub 2022 Nov 25. |
| 35088735 | Derived | Falowski SM, Kim CH, Obradovic M, Parker JL. A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement. Neuromodulation. 2022 Jul;25(5):724-730. doi: 10.1016/j.neurom.2021.11.014. Epub 2022 Jan 26. |
| 31870766 | Derived | Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20. |
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Composite Endpoint Success | 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. | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Leg Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | Intention-to-Treat (ITT) | Posted | Mean | Standard Deviation | percentage change in VAS leg pain | 3 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | Intention-to-Treat (ITT) | Posted | Mean | Standard Deviation | percentage change in VAS back pain | 3 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. | Intention-to-Treat (ITT) | Posted | Count of Participants | Participants | 3 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | Intention-to-Treat (ITT) | Posted | Count of Participants | Participants | 3 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite Endpoint Success | 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. | Intention-to-Treat (ITT) | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Leg Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | Intention-to-Treat (ITT) | Posted | Mean | Standard Deviation | percentage change in VAS leg pain | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | Intention-to-Treat (ITT) | Posted | Mean | Standard Deviation | percentage change in VAS back pain | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | Intention-to-Treat (ITT) | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain | Intention-to-Treat | Posted | Count of Participants | Participants | 12 months |
|
|
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:
Led to fetal distress, fetal death or congenital anomaly or birth defect
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 67 | 7 | 67 | 14 | 67 |
| EG001 | 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). | 0 | 67 | 4 | 67 | 15 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | custom | Systematic Assessment |
| |
| Arrhythmia and Irregularities | Cardiac disorders | custom | Systematic Assessment |
| |
| Cardiac Chest Pain | Cardiac disorders | custom | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | custom | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | custom | Systematic Assessment |
| |
| Epidural Abscess | Infections and infestations | custom | Systematic Assessment |
| |
| Facet Cyst | Musculoskeletal and connective tissue disorders | custom | Systematic Assessment |
| |
| Lead Breakage/Fracture | Product Issues | custom | Systematic Assessment |
| |
| Liver Abscess | Hepatobiliary disorders | custom | Systematic Assessment |
| |
| Renal Insufficiency | Renal and urinary disorders | custom | Systematic Assessment |
| |
| Suicidal Ideation or Attempt | Psychiatric disorders | custom | Systematic Assessment |
| |
| Transient Ischemic Attack | Vascular disorders | custom | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | custom | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Symptoms or Upper Respiratory Tract Infection | Infections and infestations | custom | Systematic Assessment |
| |
| Fall or Trip or Slip or Twist | Injury, poisoning and procedural complications | custom | Systematic Assessment |
| |
| Lead Migration | Product Issues | custom | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | custom | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Leitner | Saluda Medical | 651-208-4223 | angela.leitner@saludamedical.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2018 | May 3, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|