NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Device: Neurostimulation System

• Registration Number: NCT03240588
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-11
• Study Start: 2017-07-31
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Primary Completion: 2024-03-08
• Study Completion: 2024-03-08
• Results First Submitted: 2025-03-07
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Results First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 544

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boston Scientific SCS Systems (Day 0 IPG Activation)	Neurostimulation System	All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Boston Scientific SCS Systems (Day 0 SCS Trial Procedure)	Neurostimulation System	All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Boston Scientific SCS Systems (Day 0 Enrollment)	Neurostimulation System	All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus.

Primary Outcome Measures

Name	Time	Method
Pain Responder Rate	12 months	Proportion of subjects with 50% or greater reduction in Low Back pain

Trial Locations

Locations (16)

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States

Coastal Research Institute; 🇺🇸 Carlsbad, California, United States

South Lake Pain Institute, Inc; 🇺🇸 Clermont, Florida, United States

University of Florida Shands Hospital; 🇺🇸 Gainesville, Florida, United States

Tallahassee Neurological Clinic, PA; 🇺🇸 Tallahassee, Florida, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Willis-Knighton River Cities Clinical Research Center; 🇺🇸 Shreveport, Louisiana, United States

Forest Health Medical Center; 🇺🇸 Ypsilanti, Michigan, United States

KC Pain Centers; 🇺🇸 Lee's Summit, Missouri, United States

Scroll for more (6 remaining)