CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 126 enrolled
Drug / intervention
DTM Programming +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04571242
NCT04571242N/ACompleted
CompareCT.gov

Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery

SGX Nova LLC·interventional·Posted Sep 30, 2020·Updated Jul 15, 2024

In Brief

A clinical study evaluating DTM Programming and Conventional SCS programming for Chronic Back Pain. Completed, enrolled 126 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Back Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 30, 2020
Enrollment StartAug 11, 2020
Primary CompletionAug 17, 2022
Study CompletionApr 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.8 years ago

Interventions

DTM Programmingdevice

DTM-SCS programming

Conventional SCS programmingdevice

Conventional SCS programming