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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Device: Neurostimulation System

• Study Type: Interventional
• Enrollment (Actual): 544
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
    • Tucson, Arizona, United States, 85724
      • Banner University Medical Center
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Research Institute
  • Florida
    • Clermont, Florida, United States, 34711
      • South Lake Pain Institute, Inc
    • Gainesville, Florida, United States, 32608
      • University of Florida Shands Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic, PA
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71105
      • Willis-Knighton River Cities Clinical Research Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48198
      • Forest Health Medical Center
  • Missouri
    • Lee's Summit, Missouri, United States, 64086
      • KC Pain Centers
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports and Spine, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • PCPMG Clinical Research Unit, LLC
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Center for Pain Management
    • Kirkland, Washington, United States, 98034
      • EvergreenHealth Pain Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Neurostimulation System; Spinal cord stimulation
Experimental: 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.	Device: Neurostimulation System; Spinal cord stimulation
Experimental: 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.	Device: Neurostimulation System; Spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Responder Rate	Proportion of subjects with 50% or greater reduction in Low Back pain	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, M.S., Boston Scientific Neuromodulation Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 92100126; 92366204 (Other Identifier: Boston Scientific protocol number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes