NCT03277378

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	lead placement followed by BurstDR stimulation	lead placement followed by BurstDR stimulation

Timeline

• Start date: 2017-09-22
• Primary completion: 2018-08-23
• Completion: 2018-10-12
• First posted: 2017-09-11
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

25 sites across 7 countries: United States, Australia, Austria, Germany, Italy, Netherlands, Sweden

Regulatory

• FDA-regulated device study