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Algovita Spinal Cord Stimulation System Hi-Fi Study

9. mars 2021 oppdatert av: Nuvectra

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

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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85712
        • Pain Institute of Southern Arizona
    • California
      • Newport Beach, California, Forente stater, 92660
        • Newport Beach Headache & Pain
      • Santa Rosa, California, Forente stater, 95401
        • Summit Pain Alliance
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80919
        • Spinal Diagnostics & Pain Management
    • Kansas
      • Overland Park, Kansas, Forente stater, 66210
        • Mid-America PolyClinic & Interventional Pain Management Specialists
    • Louisiana
      • Shreveport, Louisiana, Forente stater, 71105
        • WK River Cities Clinical Research Center
    • Massachusetts
      • Chestnut Hill, Massachusetts, Forente stater, 02467
        • Brigham & Women's Hospital
    • Ohio
      • Chillicothe, Ohio, Forente stater, 45601
        • Adena Spine Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Foundation
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Comprehensive Spine Center at Rhode Island Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
Enhet: Ultra-high pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components
Aktiv komparator: Traditional pulse width
Traditional pulse width stimulation using the Algovita System
Enhet: Traditional pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
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
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
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.
Weeks 12 and 25, and Months 12, 18 and 24
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.
From Trial Implant to End of Trail
Rate of surgical re-intervention of the SCS system
Tidsramme: From Permanent Implant through Month 24
Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
From Permanent Implant through Month 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nuvectra

Samarbeidspartnere

Bright Research Partners

Etterforskere

  • Studieleder: Ben Tranchina, Nuvectra

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. november 2018

Primær fullføring (Faktiske)

27. april 2020

Studiet fullført (Faktiske)

27. april 2020

Datoer for studieregistrering

Først innsendt

26. juli 2018

Først innsendt som oppfylte QC-kriteriene

7. august 2018

Først lagt ut (Faktiske)

9. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLRE 1092

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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