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Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation

CompletedNot applicableNCT02093793
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Study details

Official title
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
Interventions
  • Device: PRECISION SCS Adapted for High-Rate SCS
Sponsor
Boston Scientific Corporation
Start date
2014-03-27
Primary completion
2018-12
Sex
All
Age range
from 22 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
20

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days. * Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician * Be 22 years of age or older at the time of enrollment * Be willing and capable of giving informed consent * Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: * Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator * Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist * Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) * Have a current systemic infection, or local infection in close proximity to anticipated surgical field * Pregnant or plan to get pregnant during the course of the study or not using adequate contraception. * Be participating in another clinical study that may influence the data collected for the study

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02093793