Chronic, Intractable Pain of the Trunk and/or Lower Limbs
Conditions
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.
Interventions
DEVICElead placement followed by BurstDR stimulation
lead placement followed by BurstDR stimulation
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Trial system implant | 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. |
| Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Trial system implant | 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. |
| Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Trial system implant | 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. |
| Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Trial system implant | 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. |
| Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Trial system implant | 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. |
| Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Trial system implant | 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. |
| Programming Time Needed for Each Randomized Group | Trial system implant | The programming time observed for both randomized groups |
| Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | 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. |
| Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period | 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 | 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. |
| Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Trial system implant | 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. |
| Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion. | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion. |
| Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP) | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as wash-in period) |
| Rate of Serious Adverse Device Effects (SADE) Based on Randomization | From pre-implant to exit of the study, approximately 3 to 14 days | Rate of serious adverse device effects based on each randomized group. |
| Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response |
| Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | 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 |
| Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Trial system implant | 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. |
| Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | Trial system implant | 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'. |
| Permanent System Qualification Rate at the End of Extended Trial Period | 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 | The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period. |
| Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant |
| Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Trial system implant | 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. |
Countries
Australia, Austria, Germany, Italy, Netherlands, Sweden, United States
Participant flow
Recruitment details
The subject enrollment for the DELIVERY study began on 22 September 2017, at 23 clinical sites in the United States, Europe, and Australia. A total of 270 subjects were randomized into the two treatment groups (Anatomic Lead Placement and Targeted lead placement).
Pre-assignment details
A total of 288 subjects were screened, of which 18 subjects were withdrawn before randomization due to unmet inclusion/exclusion criteria (n=6), withdrawal of the consent (n=11) and subject was on the clinic's wait list to receive an implant only after the study closed (n=1). The last follow-up visit occurred on 27 August 2018.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (AB) Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | 135 |
| Group 2 (TB) Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | 135 |
| Total | 270 |
Baseline characteristics
| Characteristic | Group 2 (TB) | Total | Group 1 (AB) |
|---|---|---|---|
| Age, Continuous | 63.9 Years STANDARD_DEVIATION 13.8 | 62.8 Years STANDARD_DEVIATION 13.5 | 61.8 Years STANDARD_DEVIATION 13.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 21 Participants | 7 Participants |
| Race (NIH/OMB) White | 98 Participants | 201 Participants | 103 Participants |
| Region of Enrollment Australia | 7 participants | 14 participants | 7 participants |
| Region of Enrollment Austria | 3 participants | 5 participants | 2 participants |
| Region of Enrollment Germany | 11 participants | 23 participants | 12 participants |
| Region of Enrollment Italy | 4 participants | 8 participants | 4 participants |
| Region of Enrollment Netherlands | 1 participants | 2 participants | 1 participants |
| Region of Enrollment United States | 109 participants | 218 participants | 109 participants |
| Sex: Female, Male Female | 87 Participants | 165 Participants | 78 Participants |
| Sex: Female, Male Male | 48 Participants | 105 Participants | 57 Participants |
| Years of having chronic pain | 10.69 years STANDARD_DEVIATION 11.11 | 11.46 years STANDARD_DEVIATION 11.48 | 12.23 years STANDARD_DEVIATION 11.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 135 |
| other Total, other adverse events | 4 / 135 | 6 / 135 |
| serious Total, serious adverse events | 2 / 135 | 1 / 135 |
Outcome results
Primary
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
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period | 103 Participants |
| Group 2 (TB) | Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period | 93 Participants |
Comparison: The hypothesis was formally addressed as:~H0: AB - TB ≤ -15% H1: AB - TB \> -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)p-value: 0.0003Farrington- Manning non-inferioirty test
Secondary
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.
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Population: The analysis population included physicians who had performed both types of lead placement procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study | 14 Participants |
| Group 2 (TB) | Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study | 6 Participants |
Comparison: The hypothesis was formally addressed as:~H0: P ≤ 60% H1: P \> 60% where P= percentage of physician prefer anatomic placement over targeted placement.~The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level.p-value: 0.25Chi-squared
Other Pre-specified
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (AB) | Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period | 4.2 Score on a scale | Standard Deviation 2.8 |
| Group 2 (TB) | Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period | 4.3 Score on a scale | Standard Deviation 2.7 |
Other Pre-specified
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (AB) | Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period | 2.4 Score on a scale | Standard Deviation 2.6 |
| Group 2 (TB) | Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period | 2.6 Score on a scale | Standard Deviation 2.2 |
Other Pre-specified
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (AB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 0 | 4 Participants |
| Group 1 (AB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 1 | 3 Participants |
| Group 1 (AB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 2 | 4 Participants |
| Group 1 (AB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 3 | 13 Participants |
| Group 1 (AB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 4 | 46 Participants |
| Group 1 (AB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | This was my usual practice | 59 Participants |
| Group 2 (TB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 4 | 11 Participants |
| Group 2 (TB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 0 | 1 Participants |
| Group 2 (TB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 3 | 4 Participants |
| Group 2 (TB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 1 | 3 Participants |
| Group 2 (TB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | This was my usual practice | 101 Participants |
| Group 2 (TB) | Clinician Affinity for Lead Placement Technique at the End of Trial Procedure | 2 | 3 Participants |
Other Pre-specified
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | No difficulty | 113 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Little difficulty | 12 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Moderate difficulty | 4 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Severe difficulty | 0 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Extreme difficulty | 0 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Could not place leads | 0 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | No difficulty | 82 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Little difficulty | 28 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Moderate difficulty | 14 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Severe difficulty | 1 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Extreme difficulty | 2 Participants |
| Group 1 (AB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Could not place leads | 2 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Extreme difficulty | 0 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | No difficulty | 99 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | No difficulty | 77 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Little difficulty | 17 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Severe difficulty | 1 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Moderate difficulty | 7 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Little difficulty | 28 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Severe difficulty | 0 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Could not place leads | 1 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Extreme difficulty | 0 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Lead placement difficulty | Moderate difficulty | 16 Participants |
| Group 2 (TB) | Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty | Anesthesia related difficulty | Could not place leads | 0 Participants |
Other Pre-specified
Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type | 2 Participants |
| Group 2 (TB) | Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type | 0 Participants |
Other Pre-specified
Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group | 1 Participants |
| Group 2 (TB) | Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group | 1 Participants |
Other Pre-specified
Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (AB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | ≥ 50% patient reported pain relief (PRP) | 107 Participants |
| Group 1 (AB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Trial period lasted for a minimum of 3 days | 126 Participants |
| Group 1 (AB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Physician recommendation for permanent implant | 109 Participants |
| Group 1 (AB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Subject's willingness for a permanent implant | 106 Participants |
| Group 2 (TB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Subject's willingness for a permanent implant | 100 Participants |
| Group 2 (TB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | ≥ 50% patient reported pain relief (PRP) | 99 Participants |
| Group 2 (TB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Physician recommendation for permanent implant | 104 Participants |
| Group 2 (TB) | Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant | Trial period lasted for a minimum of 3 days | 122 Participants |
Other Pre-specified
Permanent System Qualification Rate at the End of Extended Trial Period
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Permanent System Qualification Rate at the End of Extended Trial Period | 5 Participants |
| Group 2 (TB) | Permanent System Qualification Rate at the End of Extended Trial Period | 11 Participants |
Other Pre-specified
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)
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
Population: Subjects include those who had one permanent lead implanted in sites outside the United States.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Overall procedure time | 59.6 Minutes | Standard Deviation 16.2 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Implant procedure time | 11.6 Minutes | Standard Deviation 9.4 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Intraoperative fluoroscopy time | 2.12 Minutes | Standard Deviation 0.88 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Overall procedure time | 68.6 Minutes | Standard Deviation 19.7 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Implant procedure time | 22.6 Minutes | Standard Deviation 12.2 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) | Intraoperative fluoroscopy time | 2.83 Minutes | Standard Deviation 1.64 |
Other Pre-specified
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)
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
Population: Subjects include those who had one trial lead implanted in sites outside the United States.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Overall procedure time | 38 Minutes | Standard Deviation 11.8 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Implant procedure time | 11.6 Minutes | Standard Deviation 6.8 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Intraoperative fluoroscopy time | 4.22 Minutes | Standard Deviation 2.56 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Overall procedure time | 46.2 Minutes | Standard Deviation 19.2 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Implant procedure time | 21.5 Minutes | Standard Deviation 15.5 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) | Intraoperative fluoroscopy time | 4.28 Minutes | Standard Deviation 2.68 |
Other Pre-specified
Procedural Characteristics of Subjects With One Trial Lead Implanted (US)
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
Population: Subjects include those who had one trial lead implanted in sites in the United States.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Overall procedure time | 57.3 Minutes | Standard Deviation 4.7 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Implant procedure time | 38 Minutes | Standard Deviation 9.4 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Intraoperative fluoroscopy time | 2.48 Minutes | Standard Deviation 1.95 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Overall procedure time | 52.9 Minutes | Standard Deviation 16.9 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Implant procedure time | 30.3 Minutes | Standard Deviation 14.2 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (US) | Intraoperative fluoroscopy time | 2.65 Minutes | Standard Deviation 2.05 |
Other Pre-specified
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)
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
Population: Subjects include those who had one trial lead implanted in sites worldwide
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Overall procedure time | 45.0 Minutes | Standard Deviation 13.6 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Implant procedure time | 21.2 Minutes | Standard Deviation 15.2 |
| Group 1 (AB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Intraoperative fluoroscopy time | 3.59 Minutes | Standard Deviation 2.42 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Overall procedure time | 49.8 Minutes | Standard Deviation 17.6 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Implant procedure time | 26.2 Minutes | Standard Deviation 14.9 |
| Group 2 (TB) | Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) | Intraoperative fluoroscopy time | 3.40 Minutes | Standard Deviation 2.41 |
Other Pre-specified
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)
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
Population: Subjects include those who had two permanent leads implanted in sites outside the United States.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Overall procedure time | 56 Minutes | Standard Deviation 4.6 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Implant procedure time | 19.3 Minutes | Standard Deviation 5.1 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Intraoperative fluoroscopy time | 5.96 Minutes | Standard Deviation 3.09 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Overall procedure time | 92.3 Minutes | Standard Deviation 23.7 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Implant procedure time | 27.3 Minutes | Standard Deviation 6.5 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) | Intraoperative fluoroscopy time | 4.93 Minutes | Standard Deviation 4.45 |
Other Pre-specified
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)
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
Population: Subjects include those who had two trial leads implanted in sites outside the United States.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Overall procedure time | 45.9 Minutes | Standard Deviation 10.4 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Implant procedure time | 19.1 Minutes | Standard Deviation 11.7 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Intraoperative fluoroscopy time | 3.5 Minutes | Standard Deviation 1.56 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Overall procedure time | 57.3 Minutes | Standard Deviation 15.8 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Implant procedure time | 30 Minutes | Standard Deviation 14.2 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) | Intraoperative fluoroscopy time | 3.24 Minutes | Standard Deviation 1.24 |
Other Pre-specified
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)
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
Population: Subjects include those who had two trial leads implanted in sites in the United States.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Overall procedure time | 40 Minutes | Standard Deviation 12.4 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Implant procedure time | 14 Minutes | Standard Deviation 8.2 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Intraoperative fluoroscopy time | 1.52 Minutes | Standard Deviation 0.98 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Overall procedure time | 45 Minutes | Standard Deviation 13.7 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Implant procedure time | 19.9 Minutes | Standard Deviation 10 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) | Intraoperative fluoroscopy time | 1.68 Minutes | Standard Deviation 1.24 |
Other Pre-specified
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)
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
Population: Subjects include those who had two trial leads implanted in sites worldwide
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Overall procedure time | 40.4 Minutes | Standard Deviation 12.3 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Implant procedure time | 14.3 Minutes | Standard Deviation 8.5 |
| Group 1 (AB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Intraoperative fluoroscopy time | 1.65 Minutes | Standard Deviation 1.13 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Overall procedure time | 45.9 Minutes | Standard Deviation 14.1 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Implant procedure time | 20.6 Minutes | Standard Deviation 10.6 |
| Group 2 (TB) | Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) | Intraoperative fluoroscopy time | 1.79 Minutes | Standard Deviation 1.3 |
Other Pre-specified
Programming Time Needed for Each Randomized Group
The programming time observed for both randomized groups
Time frame: Trial system implant
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (AB) | Programming Time Needed for Each Randomized Group | 5 Minutes | Standard Deviation 6.4 |
| Group 2 (TB) | Programming Time Needed for Each Randomized Group | 6 Minutes | Standard Deviation 6 |
Other Pre-specified
Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion. | 1 Participants |
| Group 2 (TB) | Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion. | 2 Participants |
Other Pre-specified
Rate of Serious Adverse Device Effects (SADE) Based on Randomization
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (AB) | Rate of Serious Adverse Device Effects (SADE) Based on Randomization | 1 Participants |
| Group 2 (TB) | Rate of Serious Adverse Device Effects (SADE) Based on Randomization | 1 Participants |
Other Pre-specified
Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)
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
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (AB) | Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP) | 3.0 Days | Standard Deviation 2 |
| Group 2 (TB) | Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP) | 3.3 Days | Standard Deviation 2.8 |