NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems
NAVITAS and ENVISION Study: A Study to Characterize the Relationship Between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients Treated With Boston Scientific Neurostimulation Systems
2 other identifiers
interventional
544
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedStudy Start
First participant enrolled
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2024
CompletedResults Posted
Study results publicly available
May 8, 2025
CompletedMay 8, 2025
May 1, 2025
6.6 years
July 11, 2017
March 7, 2025
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Responder Rate
Proportion of subjects with 50% or greater reduction in Low Back pain
12 months
Study Arms (3)
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study
EXPERIMENTALPatients 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.
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study
EXPERIMENTALPatients 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.
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study
EXPERIMENTALPatients 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.
Interventions
Spinal cord stimulation
Eligibility Criteria
You may qualify if:
- \- Is willing and able to comply with completing protocol required assessments and evaluations
You may not qualify if:
- \- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Hope Research Institute
Phoenix, Arizona, 85018, United States
Banner University Medical Center
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Clinical Operations
- Organization
- Boston Scientific Corporation
Study Officials
- STUDY DIRECTOR
Natalie Bloom Lyons, M.S.
Boston Scientific Neuromodulation Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
August 7, 2017
Study Start
July 31, 2017
Primary Completion
March 8, 2024
Study Completion
March 8, 2024
Last Updated
May 8, 2025
Results First Posted
May 8, 2025
Record last verified: 2025-05