Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
NCT03345472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175
Last updated 2020-11-03
Summary
This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.
Conditions
Interventions
- DEVICE
-
Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Sponsors & Collaborators
-
MedtronicNeuro
lead INDUSTRY
Principal Investigators
-
Vectors Post Market Clinical Research Study Team · Medtronic Restorative Therapies, Pain Therapy
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-30
- Primary Completion
- 2019-02-04
- Completion
- 2019-10-21
- FDA Device
- Yes
Countries
- United States
Study Locations
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