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Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation

NCT02924129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-01-03

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.

Conditions

Interventions

DEVICE

Evoke Spinal Cord Stimulator (SCS) System

Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).

Sponsors & Collaborators

  • Saluda Medical Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Dan Brounstein, MBA · Saluda Medical Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-27
Primary Completion
2018-06-21
Completion
2022-09-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924129 on ClinicalTrials.gov