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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03277378




Registration number
NCT03277378
Ethics application status
Date submitted
4/09/2017
Date registered
11/09/2017

Titles & IDs
Public title
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
Scientific title
Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)
Secondary ID [1] 0 0
SJM-CIP-10116
Universal Trial Number (UTN)
Trial acronym
DELIVERY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic, Intractable Pain of the Trunk and/or Lower Limbs 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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 BurstDR™ stimulation during an initial trial evaluation period

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


Treatment: Devices: lead placement followed by BurstDR stimulation
lead placement followed by BurstDR stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
Timepoint [1] 0 0
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Secondary outcome [1] 0 0
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
Timepoint [1] 0 0
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2018
Sample size
Target
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Frankston Pain Management - Frankston
Recruitment hospital [2] 0 0
North Shore Private Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- Saint Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
West Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Austria
State/province [11] 0 0
Vienna
Country [12] 0 0
Germany
State/province [12] 0 0
Duisburg
Country [13] 0 0
Germany
State/province [13] 0 0
Düsseldorf
Country [14] 0 0
Germany
State/province [14] 0 0
Gera
Country [15] 0 0
Germany
State/province [15] 0 0
Nürnberg
Country [16] 0 0
Italy
State/province [16] 0 0
Pavia
Country [17] 0 0
Netherlands
State/province [17] 0 0
Leiderdorp
Country [18] 0 0
Netherlands
State/province [18] 0 0
Velp
Country [19] 0 0
Sweden
State/province [19] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn Capobianco, PhD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03277378