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NCT02741297

VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation

Completed NA Results posted Last updated 5 January 2021
What this trial tests

NA trial testing Spinal Cord Stimulation (SCS) System in Chronic Pain in 73 participants. Completed in 25 June 2019.

Timeline
19 April 2016
Primary endpoint
21 September 2018
25 June 2019

Quick facts

Lead sponsorBoston Scientific Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment73
Start date19 April 2016
Primary completion21 September 2018
Estimated completion25 June 2019
Sites5 locations across Italy, Netherlands, Germany, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Low Back Pain Responders Primary · 3 months

Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation

All Subjects
GroupValue95% CI
Spinal Cord Stimulation (SCS) System25
All subjects without outliers
GroupValue95% CI
Spinal Cord Stimulation (SCS) System23

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Spinal Cord Stimulation (SCS) System
Serious: 6/73 (8%)
Deaths: 0/73

Serious adverse events (8 terms)

ReactionSystemSpinal Cord Stimulation (S…
Angina UnstableCardiac disorders
Coronary Artery DiseaseCardiac disorders
Flank PainMusculoskeletal and connective tissue disorders
TenosynovitisMusculoskeletal and connective tissue disorders
ConstipationGastrointestinal disorders
HepatitisHepatobiliary disorders
PneumoniaInfections and infestations
Circulatory CollapseVascular disorders
Other adverse events (1 terms — click to expand)

ReactionSystemSpinal Cord Stimulation (S…
Implant Site InfectionInfections and infestations

Most-reported serious reactions: Angina Unstable, Coronary Artery Disease, Flank Pain, Tenosynovitis, Constipation, Hepatitis, Pneumonia, Circulatory Collapse.

Data from ClinicalTrials.gov NCT02741297 adverse events section.

Sponsor's own description

The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Spinal Cord Stimulation (SCS) System

Trials testing the same drug.

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other Boston Scientific Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02741297.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing