Status:
COMPLETED
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.
Eligibility Criteria
Inclusion
- Key
- Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
- Subject signed a valid, EC-approved informed consent form (ICF)
- Willing and able to comply with all protocol-required procedures and assessments/evaluations
- 18 years of age or older when written informed consent is obtained
- Key
Exclusion
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04073446
Start Date
October 31 2019
End Date
October 1 2021
Last Update
March 29 2023
Active Locations (1)
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1
AZ Nikolaas
Sint-Niklaas, Belgium