Clinical trial NCT03277378: Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
Official title: Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Secondary outcomes:
measure: Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Other outcomes:
measure: Procedural Characteristics of Subjects With One Trial Lead Implanted (US)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)
timeFrame: Trial system implant
measure: Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)
timeFrame: Trial system implant
measure: Programming Time Needed for Each Randomized Group
timeFrame: Trial system implant
measure: Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
measure: Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period
timeFrame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
measure: Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
measure: Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
measure: Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
measure: Rate of Serious Adverse Device Effects (SADE) Based on Randomization
timeFrame: From pre-implant to exit of the study, approximately 3 to 14 days
measure: Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
measure: Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type
timeFrame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
measure: Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty
timeFrame: Trial system implant
measure: Clinician Affinity for Lead Placement Technique at the End of Trial Procedure
timeFrame: Trial system implant
measure: Permanent System Qualification Rate at the End of Extended Trial Period
timeFrame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
Locations:
city: Santa Rosa
country: United States
facility: Jason Edward Pope, MD
state: California
city: Clearwater
country: United States
facility: Comprehensive Spine Institute
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Winter Park
country: United States
facility: National Pain Institute Winter Park
state: Florida
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Las Vegas
country: United States
facility: Advanced Pain Care
state: Nevada
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Tualatin
country: United States
facility: Spinal Diagnostics
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Huntington
country: United States
facility: St. Mary's Hospital
state: West Virginia
city: Frankston
country: Australia
facility: Frankston Pain Management
city: Saint Leonards
country: Australia
facility: North Shore Private Hospital
city: Graz
country: Austria
facility: Hospital Elisabethinen GmbH
city: Vienna
country: Austria
facility: Wilhelminenspital Wien
city: Duisburg
country: Germany
facility: Sana Kliniken Duisburg Gm.bH
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
city: Gera
country: Germany
facility: Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Sud
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
city: Velp
country: Netherlands
facility: Stichting Rijnstate Ziekenhuis - Velp
city: Uppsala
country: Sweden
facility: University Hospital
Study officials:
affiliation: Abbott
name: Robyn Capobianco, PhD
role: STUDY_DIRECTOR
References: