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N/A N=35 Basic Science

Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

Chronic Pain

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Patient Comfort — 30 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Programming (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boston Scientific Corporation
Primary completion
Dec 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Comfort
30

Summary

This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Eligibility Criteria

Key Inclusion Criteria

  • Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).
  • Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
  • Subject is 18 years of age or older when written informed consent is obtained.

Key Exclusion Criteria

  • Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02988713). 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.

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