MedTrace Logo

Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

NCT03680846 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2021-10-12

No results posted yet for this study

Summary

This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.

Conditions

Interventions

DEVICE

HF10 Therapy

Senza 10 kHz 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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2020-10-06
Completion
2022-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03680846 on ClinicalTrials.gov