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N/A N=231 Treatment

ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

Chronic Pain · Back Pain · Pain

Bottom Line

View on ClinicalTrials.gov: NCT04319887 ↗
Enrolled (actual)
231
Serious AEs
12.7%
Results posted
Dec 2024
Primary outcome: Primary: Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System — 1.3 ratio

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Evoke Spinal Cord Stimulation (SCS) System (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Saluda Medical Pty Ltd
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System		 1.3 —

Summary

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.

Eligibility Criteria

Inclusion Criteria

  • Subject has chronic intractable pain of the trunk and/or limbs.
  • Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria

  • Subject is unable to operate the system.
  • Subject is an unsuitable surgical candidate.
  • Subject has a condition currently requiring or likely to require the use of diathermy.
  • Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
  • Subject is <18 years old.
  • Subject is pregnant or nursing.
  • Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
  • Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04319887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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