| 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
| The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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) | Farrington- Manning non-inferioirty test | | 0.0003 | | | | | | | | | | | | | | Non-Inferiority | The hypothesis was tested at the 5% significance level. | |
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| 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. | The analysis population included physicians who had performed both types of lead placement procedures. | Posted | | Count of Participants | | Participants | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Physicians Who Prefer Anatomic Lead Placement | Physicians who preferred anatomic placement of leads | | OG001 | Physicians Who Prefer Targeted Placement of Leads | Physicians who prefered targeted placement of leads |
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| 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. | Subjects include those who had one trial lead implanted in sites in the United States. | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had one trial lead implanted in sites outside the United States. | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had one trial lead implanted in sites worldwide | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had two trial leads implanted in sites in the United States. | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had two trial leads implanted in sites outside the United States. | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had two trial leads implanted in sites worldwide | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had one permanent lead implanted in sites outside the United States. | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | Subjects include those who had two permanent leads implanted in sites outside the United States. | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| Other Pre-specified | Programming Time Needed for Each Randomized Group | The programming time observed for both randomized groups | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | Minutes | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | Score on a scale | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | Score on a scale | | 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 | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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") | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | Days | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| Other Pre-specified | Rate of Serious Adverse Device Effects (SADE) Based on Randomization | Rate of serious adverse device effects based on each randomized group. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | From pre-implant to exit of the study, approximately 3 to 14 days | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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 | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation | | | | ID | Title | Description |
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| OG000 | Subjects With Temporary Lead Implant | Subjects who had temporary lead implant after randomization | | OG001 | Subjects With Permanent Lead Implant | Subjects who had Permanent lead implant after randomization |
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| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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'. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Trial system implant | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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| 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. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | 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 | | | | ID | Title | Description |
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| OG000 | Group 1 (AB) | Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period | | OG001 | Group 2 (TB) | Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period |
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