Health TrialsbyHealthPanel

Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).

ConditionsPainChronic PainNeuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Francis Hospital

About this trial

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Evoke

    Device

    The Saluda Medical Evoke® CL-SCS System (Evoke System). The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

VAS - Visual Analog Scale

Time frame
Baseline to 12 months

Secondary outcomes

1

PROMIS-29

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint Francis Hospital

Lead sponsor

Saluda Medical Americas, Inc.

Collaborator

Source ClinicalTrials.gov
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