Trial Outcomes & Findings for NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems (NCT NCT03240588)

NCT ID: NCT03240588

Last Updated: 2025-05-08

Results Overview

Proportion of subjects with 50% or greater reduction in Low Back pain

Recruitment status

COMPLETED

Study phase

Target enrollment

544 participants

Primary outcome timeframe

12 months

Results posted on

2025-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus. Neurostimulation System: Spinal cord stimulation	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation	Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation
Overall Study STARTED	363	150	31
Overall Study COMPLETED	178	54	21
Overall Study NOT COMPLETED	185	96	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus. Neurostimulation System: Spinal cord stimulation	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation	Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation
Overall Study Death	3	0	0
Overall Study Adverse Event	5	4	0
Overall Study Lost to Follow-up	9	4	0
Overall Study Physician Decision	3	2	0
Overall Study Did not meet eligibility criteria	0	6	0
Overall Study No longer meets protocol criteria	12	7	0
Overall Study Withdrawal by Subject	60	52	7
Overall Study Other, additional details not available.	0	12	1
Overall Study Attempted to implant study device but unable to do so/unsuccessful neurostimulation trial procedure	14	3	0
Overall Study Closure of study	55	3	0
Overall Study Subject non-compliance	23	2	1
Overall Study Device Deficiency	1	0	0
Overall Study End of study information not provided to determine reason for withdrawal.	0	1	1

Baseline Characteristics

Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study n=359 Participants Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus. Neurostimulation System: Spinal cord stimulation	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study n=149 Participants Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation	Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study n=31 Participants Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation	Total n=539 Participants Total of all reporting groups
Age, Customized Age	61.2 years STANDARD_DEVIATION 11.7 • n=298 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	58.6 years STANDARD_DEVIATION 12.5 • n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	60.1 years STANDARD_DEVIATION 10.4 • n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	60.3 years STANDARD_DEVIATION 11.9 • n=478 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Sex: Female, Male Female	181 Participants n=298 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	97 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	18 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	296 Participants n=478 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Sex: Female, Male Male	117 Participants n=298 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	52 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	13 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	182 Participants n=478 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized American Indian or Alaska native	2 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	2 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	1 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	5 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Asian	0 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Black, of African heritage	19 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	14 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	5 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	38 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Caucasian	261 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	120 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	25 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	406 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Hispanic or Latino	15 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	8 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	23 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	1 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Other	0 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	1 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	1 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Race/Ethnicity, Customized Not disclosed	6 Participants n=304 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	7 Participants n=149 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	0 Participants n=31 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	13 Participants n=484 Participants • Data is based on all available data. More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Region of Enrollment United States	359 Participants n=359 Participants • More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	149 Participants n=149 Participants • More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	31 Participants n=31 Participants • More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.	539 Participants n=539 Participants • More subjects in the "Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study" Arm/Group completed the Baseline outcome measure and Region of Enrollment (359) than the Age and Sex Baseline measures which had 298 patients and the Race/Ethnicity which had 304.
Overall Pain Numeric Rating Scale (NRS) at Baseline	5.9 units on a scale STANDARD_DEVIATION 2.3 • n=359 Participants • Data is based on all available data.	7.6 units on a scale STANDARD_DEVIATION 1.6 • n=148 Participants • Data is based on all available data.	7.3 units on a scale STANDARD_DEVIATION 1.4 • n=30 Participants • Data is based on all available data.	6.5 units on a scale STANDARD_DEVIATION 2.2 • n=537 Participants • Data is based on all available data.

PRIMARY outcome

Timeframe: 12 months

Proportion of subjects with 50% or greater reduction in Low Back pain

Outcome measures

Outcome measures
Measure	Boston Scientific SCS Systems (Day 0 Enrollment) n=215 Participants All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus. Neurostimulation System: Spinal cord stimulation	Boston Scientific SCS Systems (Day 0 SCS Trial Procedure) n=67 Participants All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation	Boston Scientific SCS Systems (Day 0 IPG Activation) n=29 Participants All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation
Pain Responder Rate	158 Participants	49 Participants	21 Participants

Adverse Events

Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study

Serious events: 51 serious events

Other events: 0 other events

Deaths: 3 deaths

Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study

Serious events: 12 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study n=363 participants at risk Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus. Neurostimulation System: Spinal cord stimulation	Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study n=150 participants at risk Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation	Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study n=31 participants at risk Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Neurostimulation System: Spinal cord stimulation
General disorders Implant site pain	0.00% 0/363 • From the time a subject sign the study Informed Consent through 3-year visit (NAVITAS), 4-year visit (ENVISION) or study withdrawal. Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.	0.00% 0/150 • From the time a subject sign the study Informed Consent through 3-year visit (NAVITAS), 4-year visit (ENVISION) or study withdrawal. Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.	6.5% 2/31 • Number of events 2 • From the time a subject sign the study Informed Consent through 3-year visit (NAVITAS), 4-year visit (ENVISION) or study withdrawal. Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study. All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.

Additional Information

Sr. Director, Clinical Operations

Boston Scientific Corporation

Phone: 855-213-9890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
Publication restrictions are in place

Restriction type: OTHER