Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain

Study Overview
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Brief Summary
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The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.

Official Title
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Real-world Evaluation of Outcome Data Under a Prospective, Observational, Post-Market Clinical Study, Using the Algovita SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs Per the Applicable Indications for Use

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Algovita Spinal Cord Stimulation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement Patient had successful Algovita SCS system stimulation trial with an Algovita SCS system and will be implanted with a permanent Algovita SCS system; prior approval must be obtained from the Sponsor if another SCS system was used for the stimulation trial Patient is willing and able to sign an IRB/EC approved informed consent, and in the United States, a Privacy Protection Authorization, as required Exclusion Criteria: Patient is contraindicated for an Algovita SCS system Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments Patient has a life expectancy of less than 2 years Patient is participating in another clinical study that would confound data analysis Patient has a coexisting pain condition that might confound pain ratings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Algovita Spinal Cord Stimulation system|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in targeted pain compared to baseline | Percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. | 6 Month Follow-up Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in targeted pain compared to baseline | Percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. | 1, 3, 12, 18, and 24 Month Follow-up Visits | 
| Percent change in targeted pain intensity compared to baseline | Percent reduction or actual reduction from baseline in targeted pain intensity, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | 
| Change in disability compared to baseline | Change from baseline in disability as measured by Oswestry Disability Index (ODI). The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | 
| Change in quality of life compared to baseline | Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | 
| Willingness to undergo procedure again | To record the participants willingness to undergo the procedure again using a question (yes/no) if the participant would be willing to undergo the procedure again. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | 
| Rate of device-related and/or procedure-related Adverse Events (AEs) | To record the rate of device-related and/or procedure-related Adverse Events (AEs). | From Implant through 24 Month Follow-up Visit | 
| Rate of surgical intervention of the SCS system | To record the rate of surgical intervention of the SCS system. | From Implant through 24 Month Follow-up Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation, chronic pain, failed back surgery syndrome