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NCT03240588 Clinical Trial

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

Pain, Chronic Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03240588
Other study ID # 92100126
Secondary ID 92366204
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2017
Est. completion date March 8, 2024

Study information
Verified date April 2024
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 544
Est. completion date March 8, 2024
Est. primary completion date March 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Neurostimulation System
Spinal cord stimulation

Locations
Country Name City State
United States Washington Center for Pain Management Bellevue Washington
United States Coastal Research Institute Carlsbad California
United States South Lake Pain Institute, Inc Clermont Florida
United States Pacific Sports and Spine, LLC Eugene Oregon
United States University of Florida Shands Hospital Gainesville Florida
United States PCPMG Clinical Research Unit, LLC Greenville South Carolina
United States EvergreenHealth Pain Care Kirkland Washington
United States KC Pain Centers Lee's Summit Missouri
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Hope Research Institute Phoenix Arizona
United States Willis-Knighton River Cities Clinical Research Center Shreveport Louisiana
United States Tallahassee Neurological Clinic, PA Tallahassee Florida
United States Banner University Medical Center Tucson Arizona
United States Precision Spine Care Tyler Texas
United States The Center for Clinical Research, LLC Winston-Salem North Carolina
United States Forest Health Medical Center Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Responder Rate Proportion of subjects with 50% or greater reduction in pain 12 months
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