Pain, ChronicNCT03240588

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

A study testing Neurostimulation System in people with Pain, Chronic, run by Boston Scientific Corporation at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Chronic
What is being tested?: Neurostimulation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 544 participants
Where: 16 sitesUnited States
Study dates: 31 Jul 2017to 8 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is willing and able to comply with completing protocol required assessments and evaluations

Who cannot join

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)

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Washington Center for Pain Management
Bellevue, Washington, 98004
Coastal Research Institute
Carlsbad, California, 92009
South Lake Pain Institute, Inc
Clermont, Florida, 34711
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
University of Florida Shands Hospital
Gainesville, Florida, 32608
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
EvergreenHealth Pain Care
Kirkland, Washington, 98034
KC Pain Centers
Lee's Summit, Missouri, 64086
Ochsner Clinic Foundation
New Orleans, Louisiana, 70115
Hope Research Institute
Phoenix, Arizona, 85018
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, 32308
Banner University Medical Center
Tucson, Arizona, 85724
Precision Spine Care
Tyler, Texas, 75701
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
Forest Health Medical Center
Ypsilanti, Michigan, 48198

Other trials in United States

About this study

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

Conditions: Pain, Chronic
Being tested: Neurostimulation System
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neurostimulation SystemDevice
Spinal cord stimulation

Study groups in NCT03240588
Study group	Role	What they receive
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study	Experimental	Patients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus. Receives: Device: Neurostimulation System
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study	Experimental	Patients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Receives: Device: Neurostimulation System
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study	Experimental	Patients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain. Receives: Device: Neurostimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Responder Rate
Proportion of subjects with 50% or greater reduction in Low Back pain
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 20178 Mar 2024

First posted7 Aug 2017
Study start31 Jul 2017
Primary completion8 Mar 2024
Study completion8 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, ChronicStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 544 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03240588
Sponsor's protocol ID: 92100126
Other IDs: 92366204
Status last verified: May 2025
First submitted: 11 Jul 2017
Last updated: 8 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03240588
Acronym / sponsor ID: 92100126
Conditions: Pain, Chronic
Study type: Interventional
Recruitment status: Completed
Enrolment: 544 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 31 Jul 2017 (actual)
Primary completion: 8 Mar 2024 (actual)
Study completion: 8 Mar 2024 (actual)
First posted: 7 Aug 2017 (actual)
Results: Posted 8 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study	Experimental	Device: Neurostimulation SystemPatients enrolled in the ENVISION study. Follow-up period is based on date they signed the informed consent and were enrolled into the study. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain, except for Precision™ and Precision™ Plus.
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study	Experimental	Device: Neurostimulation SystemPatients enrolled in the NAVITAS study. Follow-up period is based on date of their SCS Trial Procedure. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study	Experimental	Device: Neurostimulation SystemPatients enrolled in the NAVITAS study. Follow-up period is based on date of their Implantable Pulse Generator (IPG) was activated. All commercially approved Boston Scientific neurostimulation systems indicated for the treatment of chronic pain.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Is willing and able to comply with completing protocol required assessments and evaluations

Key exclusion criteria (1 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neurostimulation SystemSpinal cord stimulation	Device	Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study, Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study, Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study

Primary outcome

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

Results and safety

Results posted to the registry on 8 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study	363	178
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study	150	54
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study	31	21

Primary outcome: Pain Responder Rate

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Boston Scientific SCS Systems (Day 0 Enrollment) n = 215	Boston Scientific SCS Systems (Day 0 SCS Trial Procedure) n = 67	Boston Scientific SCS Systems (Day 0 IPG Activation) n = 29
Value	158	49	21

Adverse events

Time frame: From the time a subject sign the study Informed Consent through 3-year visit (NAVITAS), 4-year visit (ENVISION) or study withdrawal.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study	51 of 363 (14%)	0 of 363 (0%)	3 of 363
Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study	16 of 150 (10.7%)	0 of 150 (0%)	0 of 150
Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study	12 of 31 (38.7%)	2 of 31 (6.5%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Natalie Bloom Lyons, M.S. study director

Boston Scientific Neuromodulation Corporation

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neurostimulation System in people with Pain, Chronic, run by Boston Scientific Corporation at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Responder Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03240588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.