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TARGET Post-Approval Study

CompletedNCT02800863
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Official title
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
Conditions
  • Complex Regional Pain Syndrome (CRPS)
Interventions
  • Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
  • Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Sponsor
Abbott Medical Devices
Start date
2016-08-23
Primary completion
2021-09-23
Sex
All
Age range
from 22 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
44

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subject is male or female between ≥ 22 and ≤ 75 years of age. * Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II. * Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment. * Subject is willing and able to comply with the study requirements. * Subject is able to provide written informed consent. Exclusion Criteria: * Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators. * Subject is currently involved in medically related litigation, including workers compensation. * Subject has a life expectancy of less than one year. * Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator. * Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted. * Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted. * Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02800863