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| Name | Class |
|---|---|
| Bright Research Partners | INDUSTRY |
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The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra-high pulse width | Active Comparator | Ultra-high pulse width stimulation using the Algovita System |
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| Traditional pulse width | Active Comparator | Traditional pulse width stimulation using the Algovita System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-high pulse width stimulation | Device | Algovita Spinal Cord Stimulation System with associated components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of targeted pain reduction compared to baseline in each treatment arm | The 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. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods. | Week 25 |
| Rate of serious study-related adverse events (AEs) in each treatment arm | The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs. | From Permanent Implant through Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of targeted pain reduction compared to baseline in each treatment arm | The percentage of participants who experience at least a 50 percent reduction in targeted pain 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. | Week 12 and Months 12, 18 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Tranchina | Nuvectra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Institute of Southern Arizona | Tucson | Arizona | 85712 | United States | ||
| Newport Beach Headache & Pain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 7, 2023 | Nov 29, 2023 | 12 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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During the Treatment Phase of the study, all subjects will receive both treatments under a crossover design. Subjects will undergo 12 weeks of treatment in each group with a 1-week washout between groups.
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Subjects who receive a permanent implant will be randomly assigned in a 1:1 ratio to one of the two sequences of treatment. Randomization schedules for each site will be prepared by the contract research organization (CRO) statistician and uploaded into a role-limited module of the study database. In order to avoid any potential bias, each site will designate an unblinded coordinator (UC). The UC, Nuvectra field personnel (FP) and the CRO will be unblinded to the treatment group. The participant and other site staff will be blinded to the treatment group.
| Traditional pulse width stimulation | Device | Algovita Spinal Cord Stimulation System with associated components |
|
| Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm | The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain 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. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm | The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Change in targeted, back and/or leg pain compared to baseline in each treatment arm | The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a 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. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Change in targeted, back and/or leg pain compared to baseline in each treatment arm | The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Clinician Global Impression of Change score in each treatment arm | The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse). | Weeks 12 and 25, and Months 12, 18 and 24 |
| Change in disability compared to baseline in each treatment arm | The change from baseline in disability as measured by the Oswestry Disability Index. The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Change in quality of life compared to baseline in each treatment arm | The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Change in patient activity per the Pain Disability Index score in each treatment arm | The change from baseline in patient activity as measured by the Pain Disability Index score. The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Patient Global Impression of Change score in each treatment arm | The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse). | Weeks 12 and 25, and Months 12, 18 and 24 |
| Participant satisfaction per the subject satisfaction survey outcome in each treatment arm | Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied. | Weeks 12 and 25, and Months 12, 18 and 24 |
| Evaluation of trial success rates | The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline. | From Trial Implant to End of Trail |
| Rate of surgical re-intervention of the SCS system | Rate of surgical re-intervention of the SCS system for participants with a permanent implant. | From Permanent Implant through Month 24 |
| Newport Beach |
| California |
| 92660 |
| United States |
| Summit Pain Alliance | Santa Rosa | California | 95401 | United States |
| Spinal Diagnostics & Pain Management | Colorado Springs | Colorado | 80919 | United States |
| Mid-America PolyClinic & Interventional Pain Management Specialists | Overland Park | Kansas | 66210 | United States |
| WK River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| Brigham & Women's Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
| Adena Spine Center | Chillicothe | Ohio | 45601 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Comprehensive Spine Center at Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |