MedTrace Logo

Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain

NCT03228420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2021-08-10

Study results available
· View outcomes & findings →

Summary

This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DEVICE

Senza HF10 Therapy

Senza 10kHz Spinal Cord Stimulation

OTHER

CMM

Conventional Medical Management

Sponsors & Collaborators

  • Nevro Corp

    lead INDUSTRY

Principal Investigators

  • David Caraway, MD · Nevro Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2020-05-01
Completion
2022-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228420 on ClinicalTrials.gov