N/A
Completed N=544
NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems
Pain, Chronic
Source: ClinicalTrials.gov NCT03240588 ↗
Enrolled (actual)
544
Serious AEs
14.5%
Results posted
May 2025
Primary outcomePrimary: Pain Responder Rate — 158; 49; 21 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Responder Rate |
158; 49; 21 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03240588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.