Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

NCT03526055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-21

Study results available
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Summary

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

Conditions

  • Spinal Cord Stimulation
  • Pain, Back
  • Pain

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

  • Amol Soin

    lead OTHER

Principal Investigators

  • Amol Soin, MD, MBA · Ohio Pain Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2018-05-31
Completion
2018-05-31
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 NCT03526055 on ClinicalTrials.gov