CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 426 enrolled
Drug / intervention
Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) +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/NCT02800863
NCT02800863N/ACompleted
CompareCT.gov

TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II

Abbott Medical Devices·observational·Posted Jun 15, 2016·Updated Jul 8, 2024

In Brief

An observational study evaluating Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) and Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) for Complex Regional Pain Syndrome (CRPS). Completed, enrolled 426 participants across 44 sites.

Detailed Summary

The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsComplex Regional Pain Syndrome (CRPS)
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 15, 2016
Enrollment StartAug 23, 2016
Primary CompletionSep 23, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.0 years ago

Interventions

Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)device

Electrical stimulation of the DRG using the Axium™ Neurostimulator System

Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)device

Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.