Ryggmargsstimulering ved behandling av kroniske, uhåndterlige smerter ved hjelp av Nalu™ nevrostimuleringssystemet (nPower™-US)
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety with the Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back. Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation System.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The study is a prospective, multi-center, open-label, single-arm clinical study.
Subjects who meet the protocol specified eligibility criteria and provide documented informed consent will be considered for study participation. On confirmation of eligibility, subjects will undergo a trial with the Nalu Neurostimulation System. Trials will be done per standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in their back pain will receive a permanent implant.
Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and medical practices and will be programmed for stimulation with one or more therapies to optimize pain reduction. All subjects receiving a permanent implant will be followed for 3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up and programming, as required. Visual Analogue Scale (VAS) will be used to capture outcomes for pain, both leg and back. At study completion, subjects will return to standard clinical practice. Adverse Event data will also be collected to support a safety endpoint.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Larkspur, California, Forente stater, 94939
- CA Ortho and Spine
-
Walnut Creek, California, Forente stater, 94598
- IPM Medical Group, Inc.
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forente stater, 20006
- International Spine, Pain and Performance Center
-
-
Florida
-
Gainesville, Florida, Forente stater, 32607
- The Orthopaedic Institute
-
Port Charlotte, Florida, Forente stater, 33948
- Southwest Florida Pain Center
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30326
- Alliance Spine and Pain
-
-
Kansas
-
Overland Park, Kansas, Forente stater, 66210
- Neuroscience Research Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73106
- SSM Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subject is between 21 and 80 years of age at enrollment.
- Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.
- Subject's pain is unresponsive to conservative treatment options.
- Subject has a VAS Score of at least 6 in the back and/or leg at screening.
Exclusion Criteria:
- Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
- Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).
- Subject has pain in another anatomic region besides the leg(s) and back that would interfere with their ability to accurately report pain (e.g. hip joint pain).
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Nalu SCS System
All eligible subjects will receive the Nalu Neurostimulation System |
The Nalu Neurostimulation System is a Spinal Cord Stimulation system |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Responder Rate
Tidsramme: 3 months post device activation
|
Subjects with 50% or greater pain reduction from baseline on the VAS pain scale for leg and/or back |
3 months post device activation
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Shilpa Kottalgi, Nalu Medical
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NAL-01-2020-US
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .