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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03277378
Registration number
NCT03277378
Ethics application status
Date submitted
4/09/2017
Date registered
11/09/2017
Date last updated
5/01/2021
Titles & IDs
Public title
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
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Scientific title
Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
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Secondary ID [1]
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SJM-CIP-10116
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Universal Trial Number (UTN)
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Trial acronym
DELIVERY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic, Intractable Pain of the Trunk and/or Lower Limbs
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - lead placement followed by BurstDR stimulation
Active Comparator: Group 1 (AB) - Group 1 (AB): anatomic lead placement followed by BurstDRā¢ stimulation during an initial trial evaluation period
Active Comparator: Group 2 (TB) - Group 2 (TB): targeted lead placement followed by BurstDRā¢ stimulation during an initial trial evaluation period
Treatment: Devices: lead placement followed by BurstDR stimulation
lead placement followed by BurstDR stimulation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
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Assessment method [1]
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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
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Timepoint [1]
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From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
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Secondary outcome [1]
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Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
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Assessment method [1]
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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.
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Timepoint [1]
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From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2018
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Sample size
Target
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Accrual to date
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Final
270
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Frankston Pain Management - Frankston
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Recruitment hospital [2]
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North Shore Private Hospital - Saint Leonards
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Recruitment postcode(s) [1]
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- Frankston
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Recruitment postcode(s) [2]
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- Saint Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Kansas
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Nevada
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United States of America
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Oregon
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United States of America
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Rhode Island
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United States of America
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Texas
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United States of America
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West Virginia
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Austria
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Graz
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Austria
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Vienna
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Germany
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Duisburg
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Germany
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Düsseldorf
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Germany
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Gera
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Germany
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Nürnberg
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Italy
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Pavia
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Netherlands
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Leiderdorp
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Netherlands
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Velp
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Sweden
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State/province [19]
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Prospective, multi-center, randomized, single blind study
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03277378
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robyn Capobianco, PhD
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Address
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Abbott
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03277378
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