Back to resultsEvaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial (DELIVERY)
Primary Purpose
Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
lead placement followed by BurstDR stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Eligibility Criteria
Inclusion Criteria:
- Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
- Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
- 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.
- 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.
- Patient is >18 years of age at the time of enrollment.
- Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
- Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.
Exclusion Criteria:
- Patient currently has a spinal cord stimulation system implanted.
- Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
- Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
- Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
- Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
Sites / Locations
- Jason Edward Pope, MD
- Comprehensive Spine Institute
- Florida Pain Institute
- National Pain Institute Winter Park
- Rush University
- Kansas University Medical Center
- Advanced Pain Care
- Nevada Advanced Pain Specialists
- Oregon Health & Science University
- Spinal Diagnostics
- Rhode Island Hospital
- Precision Spine Care
- St. Mary's Hospital
- Frankston Pain Management
- North Shore Private Hospital
- Hospital Elisabethinen GmbH
- Wilhelminenspital Wien
- Sana Kliniken Duisburg Gm.bH
- Medizinische Einrichtungen der Universität Düsseldorf
- Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
- Klinikum Nürnberg Sud
- Fondazione Salvatore Maugeri
- Alrijne Ziekenhuis
- Stichting Rijnstate Ziekenhuis - Velp
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 (AB)
Group 2 (TB)
Arm Description
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
Outcomes
Primary Outcome Measures
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
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
Secondary Outcome Measures
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
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.
Full Information
NCT ID
NCT03277378
First Posted
September 4, 2017
Last Updated
December 9, 2020
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT03277378
Brief Title
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
Acronym
DELIVERY
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
October 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic, Intractable Pain of the Trunk and/or Lower Limbs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (AB)
Arm Type
Active Comparator
Arm Description
Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Arm Title
Group 2 (TB)
Arm Type
Active Comparator
Arm Description
Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Intervention Type
Device
Intervention Name(s)
lead placement followed by BurstDR stimulation
Other Intervention Name(s)
Spinal Cord Stimulation non-surgical Leads, Spinal Cord Stimulation Clinician Programmer, Spinal Cord Stimulation Patient Controller
Intervention Description
lead placement followed by BurstDR stimulation
Primary Outcome Measure Information:
Title
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
Description
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
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Secondary Outcome Measure Information:
Title
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
Description
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.
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Other Pre-specified Outcome Measures:
Title
Procedural Characteristics of Subjects With One Trial Lead Implanted (US)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)
Description
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time Frame
Trial system implant
Title
Programming Time Needed for Each Randomized Group
Description
The programming time observed for both randomized groups
Time Frame
Trial system implant
Title
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period
Description
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Title
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period
Description
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
Time Frame
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
Title
Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant
Description
Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Title
Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.
Description
Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Title
Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)
Description
Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Title
Rate of Serious Adverse Device Effects (SADE) Based on Randomization
Description
Rate of serious adverse device effects based on each randomized group.
Time Frame
From pre-implant to exit of the study, approximately 3 to 14 days
Title
Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group
Description
A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Title
Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type
Description
The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
Time Frame
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Title
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty
Description
Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.
Time Frame
Trial system implant
Title
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure
Description
Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.
Time Frame
Trial system implant
Title
Permanent System Qualification Rate at the End of Extended Trial Period
Description
The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
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.
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.
Patient is >18 years of age at the time of enrollment.
Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.
Exclusion Criteria:
Patient currently has a spinal cord stimulation system implanted.
Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Capobianco, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Jason Edward Pope, MD
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Comprehensive Spine Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Florida Pain Institute
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
National Pain Institute Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Advanced Pain Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Nevada Advanced Pain Specialists
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Spinal Diagnostics
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
St. Mary's Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Frankston Pain Management
City
Frankston
Country
Australia
Facility Name
North Shore Private Hospital
City
Saint Leonards
Country
Australia
Facility Name
Hospital Elisabethinen GmbH
City
Graz
Country
Austria
Facility Name
Wilhelminenspital Wien
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Sana Kliniken Duisburg Gm.bH
City
Duisburg
ZIP/Postal Code
47055
Country
Germany
Facility Name
Medizinische Einrichtungen der Universität Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
City
Gera
Country
Germany
Facility Name
Klinikum Nürnberg Sud
City
Nürnberg
Country
Germany
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
Country
Italy
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
Country
Netherlands
Facility Name
Stichting Rijnstate Ziekenhuis - Velp
City
Velp
Country
Netherlands
Facility Name
University Hospital
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial
We'll reach out to this number within 24 hrs