Clinical Trials Directory

Trials / Terminated

TerminatedNCT01990287

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Abbott Medical Devices · Industry
Sex
All
Age
22 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.

Conditions

Interventions

TypeNameDescription
DEVICESCS and PNfSSpinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
DEVICESCS AloneSpinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.

Timeline

Start date
2013-11-01
Primary completion
2016-02-01
Completion
2016-02-01
First posted
2013-11-21
Last updated
2016-04-13

Locations

28 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01990287. Inclusion in this directory is not an endorsement.