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| ID | Type | Description | Link |
|---|---|---|---|
| 92366204 | Other Identifier | Boston Scientific protocol number |
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The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study | Experimental | 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. |
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| Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study | Experimental | 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. |
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| Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulation System | Device | Spinal cord stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Responder Rate | Proportion of subjects with 50% or greater reduction in Low Back pain | 12 months |
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Key Inclusion Criteria:
- Is willing and able to comply with completing protocol required assessments and evaluations
Key Exclusion Criteria:
- Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation)
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons, M.S. | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85018 | United States | ||
| Banner University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2019 |
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| Tucson |
| Arizona |
| 85724 |
| United States |
| Coastal Research Institute | Carlsbad | California | 92009 | United States |
| South Lake Pain Institute, Inc | Clermont | Florida | 34711 | United States |
| University of Florida Shands Hospital | Gainesville | Florida | 32608 | United States |
| Tallahassee Neurological Clinic, PA | Tallahassee | Florida | 32308 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70115 | United States |
| Willis-Knighton River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| Forest Health Medical Center | Ypsilanti | Michigan | 48198 | United States |
| KC Pain Centers | Lee's Summit | Missouri | 64086 | United States |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Pacific Sports and Spine, LLC | Eugene | Oregon | 97401 | United States |
| PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | 29601 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| Washington Center for Pain Management | Bellevue | Washington | 98004 | United States |
| EvergreenHealth Pain Care | Kirkland | Washington | 98034 | United States |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | 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. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | 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. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | 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. | Count of Participants | Participants |
| |||||||||
| Overall Pain Numeric Rating Scale (NRS) at Baseline | The Numeric Rating Scale is a tool for patient self-reporting of pain. The scale consists of 11 points, ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable" | Data is based on all available data. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Responder Rate | Proportion of subjects with 50% or greater reduction in Low Back pain | Posted | Count of Participants | Participants | 12 months |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 3 | 363 | 51 | 363 | 0 | 363 |
| EG001 | 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 | 0 | 150 | 16 | 150 | 0 | 150 |
| EG002 | 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 | 0 | 31 | 12 | 31 | 2 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Toxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Trigeminal neuralgia | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to SCS device and procedure |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Blood glucose increased | Investigations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Spinal decompression | Surgical and medical procedures | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Lymphoedema | Vascular disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Implant site infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Bundle branch block left | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Cardiac disorder | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Corona virus infection | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Empyema | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Arthritis infective | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Escherichia sepsis | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Incision site abscess | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Large intestine infection | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Pneumonia fungal | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Pulmonary oedema | Reproductive system and breast disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Hypertensive heart disease | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Aortic valve stenosis | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Parkinson's disease | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Peripheral nerve lesion | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Spinal epidural haematoma | Nervous system disorders | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Post laminectomy syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Wrist fracture | Infections and infestations | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Acute promyelocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Medical device pain | General disorders | MedDRA | Systematic Assessment |
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| Biliary dyskinesia | Hepatobiliary disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Arteriosclerosis | Vascular disorders | MedDRA | Systematic Assessment | Not related to device and procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Boston Scientific Corporation | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Mar 7, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Asian |
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| Black, of African heritage |
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| Caucasian |
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| Hispanic or Latino |
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| Native Hawaiian or other Pacific Islander |
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| Other |
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| Not disclosed |
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