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SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)

NCT04571242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-07-15

Study results available
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Summary

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.

Conditions

  • Chronic Back Pain

Interventions

DEVICE

DTM Programming

DTM-SCS programming

DEVICE

Conventional SCS programming

Conventional SCS programming

Sponsors & Collaborators

  • SGX Nova LLC

    lead INDUSTRY

Principal Investigators

  • Ricardo Vallejo, MD · SGX Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2022-08-17
Completion
2023-04-12
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04571242 on ClinicalTrials.gov