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Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

NCT03756012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-08

Study results available
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Summary

The purpose of this study is to evaluate the effect of pulse widths \<500 μsec and \>1000 μsec on clinical outcomes during a temporary SCS trial.

Conditions

Interventions

DEVICE

Algovita Spinal Cord Stimulation System

The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

Sponsors & Collaborators

  • Ohio Pain Clinic

    collaborator OTHER

  • Kettering Health Network

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2019-10-02
Completion
2019-10-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03756012 on ClinicalTrials.gov