Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, randomized, single blind study

Detailed Description
-----------------
This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows: Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.

Official Title
-----------------
Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)

Conditions
-----------------
Chronic, Intractable Pain of the Trunk and/or Lower Limbs

Intervention / Treatment
-----------------
* Device: lead placement followed by BurstDR stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling. Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage. Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation. Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use. Patient is >18 years of age at the time of enrollment. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits. Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent. Exclusion Criteria: Patient currently has a spinal cord stimulation system implanted. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant). Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure) Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (AB)<br>Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | Device: lead placement followed by BurstDR stimulation<br>* lead placement followed by BurstDR stimulation<br>* Other names: Spinal Cord Stimulation Patient Controller;|
| Active Comparator: Group 2 (TB)<br>Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | Device: lead placement followed by BurstDR stimulation<br>* lead placement followed by BurstDR stimulation<br>* Other names: Spinal Cord Stimulation Patient Controller;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period | The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period. Qualification for permanent system implant was defined by a composite where all the following conditions were met: ≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation Trial evaluation period lasted for a minimum of 3 days Physician recommends subject for permanent system implant Subject reports a willingness to pursue a permanent system implant Subjects did not qualify for permanent system implant if they met both of the following: < 50% PRP (patient reported pain relief) at the end of the trial evaluation Trial evaluation period lasted for a minimum of 5 days | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study | The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique. | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation |