Trial Outcomes & Findings for Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial (NCT NCT03277378)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

270 participants

Primary outcome timeframe

From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

Results posted on

2021-01-05

Participant Flow

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).

A total of 288 subjects were screened, of which 18 subjects were withdrawn before randomization due to unmet inclusion/exclusion criteria (n=6), withdrawal of the consent (n=11) and subject was on the clinic's wait list to receive an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.

Participant milestones

Participant milestones
Measure	Group 1 (AB) Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Overall Study STARTED	135	135
Overall Study Received Lead Implant	129	123
Overall Study Completed Initial Trial	126	122
Overall Study Qualified for Permanent Implant	103	93
Overall Study Not Qualified for Permanent Implant	19	20
Overall Study Completed Extended Trial With Tonic Stim	8	12
Overall Study Exit Study	11	8
Overall Study COMPLETED	111	101
Overall Study NOT COMPLETED	24	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number of participants analyzed includes subjects who were available at that time of analysis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=122 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=113 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period	103 Participants	93 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=20 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=20 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study	14 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had one trial lead implanted in sites in the United States.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=4 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=7 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With One Trial Lead Implanted (US) Overall procedure time	57.3 Minutes Standard Deviation 4.7	52.9 Minutes Standard Deviation 16.9
Procedural Characteristics of Subjects With One Trial Lead Implanted (US) Implant procedure time	38 Minutes Standard Deviation 9.4	30.3 Minutes Standard Deviation 14.2
Procedural Characteristics of Subjects With One Trial Lead Implanted (US) Intraoperative fluoroscopy time	2.48 Minutes Standard Deviation 1.95	2.65 Minutes Standard Deviation 2.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had one trial lead implanted in sites outside the United States.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=7 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=6 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) Overall procedure time	38 Minutes Standard Deviation 11.8	46.2 Minutes Standard Deviation 19.2
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) Implant procedure time	11.6 Minutes Standard Deviation 6.8	21.5 Minutes Standard Deviation 15.5
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS) Intraoperative fluoroscopy time	4.22 Minutes Standard Deviation 2.56	4.28 Minutes Standard Deviation 2.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had one trial lead implanted in sites 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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=11 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=13 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) Overall procedure time	45.0 Minutes Standard Deviation 13.6	49.8 Minutes Standard Deviation 17.6
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) Implant procedure time	21.2 Minutes Standard Deviation 15.2	26.2 Minutes Standard Deviation 14.9
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide) Intraoperative fluoroscopy time	3.59 Minutes Standard Deviation 2.42	3.40 Minutes Standard Deviation 2.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had two trial leads implanted in sites in the United States.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=99 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=90 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) Overall procedure time	40 Minutes Standard Deviation 12.4	45 Minutes Standard Deviation 13.7
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) Implant procedure time	14 Minutes Standard Deviation 8.2	19.9 Minutes Standard Deviation 10
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US) Intraoperative fluoroscopy time	1.52 Minutes Standard Deviation 0.98	1.68 Minutes Standard Deviation 1.24

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had two trial leads implanted in sites outside the United States.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=7 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=7 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) Overall procedure time	45.9 Minutes Standard Deviation 10.4	57.3 Minutes Standard Deviation 15.8
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) Implant procedure time	19.1 Minutes Standard Deviation 11.7	30 Minutes Standard Deviation 14.2
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS) Intraoperative fluoroscopy time	3.5 Minutes Standard Deviation 1.56	3.24 Minutes Standard Deviation 1.24

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had two trial leads implanted in sites 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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=106 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=97 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) Intraoperative fluoroscopy time	1.65 Minutes Standard Deviation 1.13	1.79 Minutes Standard Deviation 1.30
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) Overall procedure time	40.4 Minutes Standard Deviation 12.3	45.9 Minutes Standard Deviation 14.1
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide) Implant procedure time	14.3 Minutes Standard Deviation 8.5	20.6 Minutes Standard Deviation 10.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had one permanent lead implanted in sites outside the United States.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=9 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=10 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) Overall procedure time	59.6 Minutes Standard Deviation 16.2	68.6 Minutes Standard Deviation 19.7
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) Implant procedure time	11.6 Minutes Standard Deviation 9.4	22.6 Minutes Standard Deviation 12.2
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS) Intraoperative fluoroscopy time	2.12 Minutes Standard Deviation 0.88	2.83 Minutes Standard Deviation 1.64

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: Subjects include those who had two permanent leads implanted in sites outside the United States.

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=3 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=3 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) Overall procedure time	56 Minutes Standard Deviation 4.6	92.3 Minutes Standard Deviation 23.7
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) Implant procedure time	19.3 Minutes Standard Deviation 5.1	27.3 Minutes Standard Deviation 6.5
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS) Intraoperative fluoroscopy time	5.96 Minutes Standard Deviation 3.09	4.93 Minutes Standard Deviation 4.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The programming time observed for both randomized groups

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=127 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=123 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Programming Time Needed for Each Randomized Group	5 Minutes Standard Deviation 6.4	6 Minutes Standard Deviation 6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=124 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=121 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
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	4.3 Score on a scale Standard Deviation 2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=10 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=14 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
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	2.6 Score on a scale Standard Deviation 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=126 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=122 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
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	99 Participants
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	122 Participants
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	104 Participants
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	100 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=126 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=122 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=64 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=61 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)	3.0 Days Standard Deviation 2.0	3.3 Days Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Rate of serious adverse device effects based on each randomized group.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=135 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=135 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Rate of Serious Adverse Device Effects (SADE) Based on Randomization	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=129 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=123 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=227 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=25 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=129 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=123 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Anesthesia related difficulty · No difficulty	113 Participants	99 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Anesthesia related difficulty · Little difficulty	12 Participants	17 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Anesthesia related difficulty · Moderate difficulty	4 Participants	7 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Anesthesia related difficulty · Severe difficulty	0 Participants	0 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Anesthesia related difficulty · Extreme difficulty	0 Participants	0 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Anesthesia related difficulty · Could not place leads	0 Participants	0 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Lead placement difficulty · No difficulty	82 Participants	77 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Lead placement difficulty · Little difficulty	28 Participants	28 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Lead placement difficulty · Moderate difficulty	14 Participants	16 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Lead placement difficulty · Severe difficulty	1 Participants	1 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Lead placement difficulty · Extreme difficulty	2 Participants	0 Participants
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty Lead placement difficulty · Could not place leads	2 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Trial system implant

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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'.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=129 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=123 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure 0	4 Participants	1 Participants
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure 1	3 Participants	3 Participants
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure 2	4 Participants	3 Participants
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure 3	13 Participants	4 Participants
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure 4	46 Participants	11 Participants
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure This was my usual practice	59 Participants	101 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.

Outcome measures

Outcome measures
Measure	Group 1 (AB) n=10 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=14 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Permanent System Qualification Rate at the End of Extended Trial Period	5 Participants	11 Participants

Adverse Events

Group 1 (AB)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 2 (TB)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 (AB) n=135 participants at risk Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=135 participants at risk Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Nervous system disorders Stroke	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days	0.00% 0/135 • Approximately 3 to 14 days
Injury, poisoning and procedural complications Spinal Cord Compression	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days	0.00% 0/135 • Approximately 3 to 14 days
Injury, poisoning and procedural complications Stimulation in unwanted places	0.00% 0/135 • Approximately 3 to 14 days	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days

Other adverse events

Other adverse events
Measure	Group 1 (AB) n=135 participants at risk Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=135 participants at risk Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Injury, poisoning and procedural complications Hematoma	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days	0.00% 0/135 • Approximately 3 to 14 days
Product Issues Lead Migration	1.5% 2/135 • Number of events 2 • Approximately 3 to 14 days	1.5% 2/135 • Number of events 2 • Approximately 3 to 14 days
Injury, poisoning and procedural complications Unpleasant sensations or Motor disturbances Including Involuntary Movement caused by high output	0.00% 0/135 • Approximately 3 to 14 days	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days
Injury, poisoning and procedural complications Persistant pain lead site	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days
Injury, poisoning and procedural complications Cerebrospinal fluid leakage	0.00% 0/135 • Approximately 3 to 14 days	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days
Injury, poisoning and procedural complications New leg pain on walking instead of original dysaesthetic sensation	0.00% 0/135 • Approximately 3 to 14 days	0.74% 1/135 • Number of events 1 • Approximately 3 to 14 days

Additional Information

Robyn Capobianco, PhD

Abbott

Phone: +1 512 286 4274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 (AB) n=135 Participants Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Group 2 (TB) n=135 Participants Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period	Total n=270 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	5 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	3 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	8 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Age, Continuous	61.8 Years STANDARD_DEVIATION 13.2 • n=135 Participants	63.9 Years STANDARD_DEVIATION 13.8 • n=135 Participants	62.8 Years STANDARD_DEVIATION 13.5 • n=270 Participants
Sex: Female, Male Female	78 Participants n=135 Participants	87 Participants n=135 Participants	165 Participants n=270 Participants
Sex: Female, Male Male	57 Participants n=135 Participants	48 Participants n=135 Participants	105 Participants n=270 Participants
Race (NIH/OMB) White	103 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	98 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	201 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	0 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	0 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Race (NIH/OMB) Asian	0 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	0 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	0 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	1 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	2 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Race (NIH/OMB) More than one race	0 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	0 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	0 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	14 Participants n=116 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	21 Participants n=232 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
Region of Enrollment Austria	2 participants n=135 Participants	3 participants n=135 Participants	5 participants n=270 Participants
Region of Enrollment Netherlands	1 participants n=135 Participants	1 participants n=135 Participants	2 participants n=270 Participants
Region of Enrollment Italy	4 participants n=135 Participants	4 participants n=135 Participants	8 participants n=270 Participants
Region of Enrollment Australia	7 participants n=135 Participants	7 participants n=135 Participants	14 participants n=270 Participants
Region of Enrollment Germany	12 participants n=135 Participants	11 participants n=135 Participants	23 participants n=270 Participants
Region of Enrollment United States	109 participants n=135 Participants	109 participants n=135 Participants	218 participants n=270 Participants
Years of having chronic pain	12.23 years STANDARD_DEVIATION 11.83 • n=135 Participants	10.69 years STANDARD_DEVIATION 11.11 • n=135 Participants	11.46 years STANDARD_DEVIATION 11.48 • n=270 Participants