- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03622866
Algovita Spinal Cord Stimulation System Hi-Fi Study
Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Arizona
-
Tucson, Arizona, Forenede Stater, 85712
- Pain Institute of Southern Arizona
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California
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Newport Beach, California, Forenede Stater, 92660
- Newport Beach Headache & Pain
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Santa Rosa, California, Forenede Stater, 95401
- Summit Pain Alliance
-
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80919
- Spinal Diagnostics & Pain Management
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Mid-America PolyClinic & Interventional Pain Management Specialists
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71105
- WK River Cities Clinical Research Center
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Massachusetts
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Chestnut Hill, Massachusetts, Forenede Stater, 02467
- Brigham & Women's Hospital
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Ohio
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Chillicothe, Ohio, Forenede Stater, 45601
- Adena Spine Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Comprehensive Spine Center at Rhode Island Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- Age 18-75 years old at consent.
- Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- ODI score of 41-80 out of 100 at the Baseline visit.
- Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
- On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
- Willing and capable of providing informed consent.
- Willing and able of complying with the study-related requirements, procedures, and visits.
- Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
- Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.
Exclusion Criteria:
- Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- Has a condition currently requiring or likely to require the use of MRI or diathermy.
- Has an existing drug pump, SCS System, or other active implantable device.
- Has any prior SCS experience.
- Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
- For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
- Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
- Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
Aktiv komparator: Traditional pulse width
Traditional pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Tidsramme: Week 25
|
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
Tidsramme: From Permanent Implant through Week 25
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Tidsramme: Week 12 and Months 12, 18 and 24
|
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
|
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
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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).
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Weeks 12 and 25, and Months 12, 18 and 24
|
Change in disability compared to baseline in each treatment arm
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
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Change in quality of life compared to baseline in each treatment arm
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
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
Tidsramme: Weeks 12 and 25, and Months 12, 18 and 24
|
Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
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Weeks 12 and 25, and Months 12, 18 and 24
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Evaluation of trial success rates
Tidsramme: From Trial Implant to End of Trail
|
The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
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From Trial Implant to End of Trail
|
Rate of surgical re-intervention of the SCS system
Tidsramme: From Permanent Implant through Month 24
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Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
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From Permanent Implant through Month 24
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Ben Tranchina, Nuvectra
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLRE 1092
Plan for individuelle deltagerdata (IPD)
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