Clinical trial NCT03240588: NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pain Responder Rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Carlsbad
country: United States
facility: Coastal Research Institute
state: California
city: Clermont
country: United States
facility: South Lake Pain Institute, Inc
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic, PA
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Lee's Summit
country: United States
facility: KC Pain Centers
state: Missouri
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Bellevue
country: United States
facility: Washington Center for Pain Management
state: Washington
city: Kirkland
country: United States
facility: EvergreenHealth Pain Care
state: Washington
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons, M.S.
role: STUDY_DIRECTOR
References: