Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

NCT00386724 | Terminated Results

• 1 other identifier: SCS0406
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary or secondary back or lower extremity pain. There are significant numbers of patients with FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate that the Precision SCS device has significant effectiveness in reducing this pain resulting in improved quality of life and functional capacity.

Conditions

Back Pain; Chronic Pain; Pain in Leg, Unspecified

Keywords

Pain; Neurostimulation; Leg Pain; Back Pain

Outcome Measures

Primary Outcomes (1)

• Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activation

  3 months post-activation

Study Arms (1)

Precision Spinal Cord Stimulation

EXPERIMENTAL

Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead

Device: Precision Spinal Cord Stimulation System; Device: Artisan Surgical Lead

Interventions

Precision Spinal Cord Stimulation System DEVICE

Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.

Also known as: PRECISION Spinal Cord Stimulator System

Precision Spinal Cord Stimulation

Artisan Surgical Lead DEVICE

Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.

Also known as: Artisan surgical lead with PRECISION System.

Precision Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have FBSS with moderate to severe back or lower extremity pain of at least 3 months duration, be an appropriate candidate for SCS, and have independently elected SCS therapy with the Precision system as next line therapy;
• Be 18 years of age or older;
• Be willing and able to comply with all study related procedures and visits;
• Be capable of reading and understanding patient information materials and giving written informed consent.

You may not qualify if:

• Have low back pain as the primary complaint;
• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints;
• Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Neurosurgical Specialist

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Back Pain; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Research Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

6619494350

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Locations

US (2)