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

Boston Scientific

Status: Completed

Conditions: Pain, Chronic

Treatments: Device: Neurostimulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03240588

92100126

92366204 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 544 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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544 participants in 3 patient groups

Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 Enrollment) ENVISION Study

Experimental group

Description:

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.

Treatment:

Device: Neurostimulation System

Boston Scientific Spinal Cord Stimulator (SCS) Systems (Day 0 SCS Trial Procedure) Navitas Study

Experimental group

Description:

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.

Treatment:

Device: Neurostimulation System

Boston Scientific SCS Systems (Day 0 Implantable Pulse Generator (IPG) Activation) Navitas Study

Experimental group

Description:

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.

Treatment:

Device: Neurostimulation System