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NAVITAS and ENVISION

Primary Purpose

Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurostimulation System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hope Research Institute
  • Banner University Medical CenterRecruiting
  • Coastal Research InstituteRecruiting
  • South Lake Pain Institute, IncRecruiting
  • University of Florida Shands HospitalRecruiting
  • Tallahassee Neurological Clinic, PARecruiting
  • Ochsner Clinic FoundationRecruiting
  • Willis-Knighton River Cities Clinical Research CenterRecruiting
  • Forest Health Medical CenterRecruiting
  • KC Pain CentersRecruiting
  • The Center for Clinical Research, LLCRecruiting
  • Pacific Sports and Spine, LLCRecruiting
  • PCPMG Clinical Research Unit, LLC
  • Precision Spine Care
  • Washington Center for Pain Management
  • EvergreenHealth Pain Care
  • Advanced Pain Management Appleton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

De Novo Cohort

Existing Cohort

Arm Description

Study subjects who have not previously attempted a Neurostimulator trial will be followed up to 36 months post-Neurostimulation trial procedure or IPG Activation on the use of their Neurostimulation system.

Study subjects who have completed permanent neurostimulator IPG implant and are in various stages of follow-up will be followed up to 36 months post-Neurostimulation trial or IPG Activation procedure on the use of their Neurostimulation system.

Outcomes

Primary Outcome Measures

Pain Intensity
Mean difference in pain intensity between Baseline and 6 months post neurostimulation trial visit (pain intensity assessed using 0-10 numerical rating scale)

Secondary Outcome Measures

Full Information

First Posted
July 11, 2017
Last Updated
October 3, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03240588
Brief Title
NAVITAS and ENVISION
Official Title
NAVITAS and ENVISION: 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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
De Novo Cohort
Arm Type
Active Comparator
Arm Description
Study subjects who have not previously attempted a Neurostimulator trial will be followed up to 36 months post-Neurostimulation trial procedure or IPG Activation on the use of their Neurostimulation system.
Arm Title
Existing Cohort
Arm Type
Active Comparator
Arm Description
Study subjects who have completed permanent neurostimulator IPG implant and are in various stages of follow-up will be followed up to 36 months post-Neurostimulation trial or IPG Activation procedure on the use of their Neurostimulation system.
Intervention Type
Device
Intervention Name(s)
Neurostimulation System
Intervention Description
Spinal cord stimulation
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Mean difference in pain intensity between Baseline and 6 months post neurostimulation trial visit (pain intensity assessed using 0-10 numerical rating scale)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerard Herro, MS
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Keesey
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons, M.S.
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Terminated
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Coastal Research Institute
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
South Lake Pain Institute, Inc
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Tallahassee Neurological Clinic, PA
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Willis-Knighton River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Forest Health Medical Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
KC Pain Centers
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Pacific Sports and Spine, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Terminated
Facility Name
Washington Center for Pain Management
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Terminated
Facility Name
EvergreenHealth Pain Care
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Terminated
Facility Name
Advanced Pain Management Appleton
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States
Individual Site Status
Terminated

12. IPD Sharing Statement

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NAVITAS and ENVISION

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