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Spinal Cord Stimulation
CMM Alone for Diabetic Neuropathy (SENZA-PDN Trial)
N/A
Waitlist Available
Research Sponsored by Nevro Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
SENZA-PDN Trial Summary
This trial is testing whether adding HF10 therapy to a common pain treatment can help people with chronic neuropathic pain due to diabetes.
Eligible Conditions
- Diabetic Neuropathy
SENZA-PDN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of Safety and Effectiveness
Secondary outcome measures
Crossover Rates
Health-related Quality of Life
Hemoglobin A1c
+4 moreSENZA-PDN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CMM AloneExperimental Treatment1 Intervention
Conventional Medical Management
Group II: HF10 therapy plus CMMActive Control1 Intervention
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
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Who is running the clinical trial?
Nevro CorpLead Sponsor
7 Previous Clinical Trials
1,467 Total Patients Enrolled
David Caraway, MDStudy DirectorNevro Corp
5 Previous Clinical Trials
853 Total Patients Enrolled
Frequently Asked Questions
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