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Trial record 1 of 1 for:    NCT03240588
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03240588
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 3, 2022
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Device: Neurostimulation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: De Novo Cohort
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.
Device: Neurostimulation System
Spinal cord stimulation

Active Comparator: Existing Cohort
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.
Device: Neurostimulation System
Spinal cord stimulation

Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 6 months ]
    Mean difference in pain intensity between Baseline and 6 months post neurostimulation trial visit (pain intensity assessed using 0-10 numerical rating scale)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03240588

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Contact: Gerard Herro, MS 855-213-9890
Contact: Diane Keesey 855-213-9890

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Sponsors and Collaborators
Boston Scientific Corporation
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Study Director: Roshini Jain, M.S. Boston Scientific Neuromodulation Corporation
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Responsible Party: Boston Scientific Corporation Identifier: NCT03240588    
Other Study ID Numbers: 92100126
92366204 ( Other Identifier: Boston Scientific )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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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
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations