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

Abbott

Status: Completed

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

Treatments: Device: lead placement followed by BurstDR stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03277378

SJM-CIP-10116

Details and patient eligibility

About

Prospective, multi-center, randomized, single blind study

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
2. Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
3. 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.
4. 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.
5. Patient is >18 years of age at the time of enrollment.
6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
7. Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.

Exclusion criteria

1. Patient currently has a spinal cord stimulation system implanted.
2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

Group 1 (AB)

Active Comparator group

Description:

Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

Treatment:

Device: lead placement followed by BurstDR stimulation

Group 2 (TB)

Active Comparator group

Description:

Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

Treatment:

Device: lead placement followed by BurstDR stimulation