TARGET Post-Approval Study

Completed

Conditions studied: Complex Regional Pain Syndrome (CRPS)

In brief

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.

Key facts

Study ID: NCT02800863
Run by: Abbott Medical Devices
People needed: 426
Starts: 2016-08-23
Expected to finish: 2021-09-23
Last updated by the study team: 2024-07-08

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Arizona Pain Specialists — Scottsdale, Arizona, United States
Spanish Hills Interventional Pain Specialists — Camarillo, California, United States
California Orthopedics & Spine — Larkspur, California, United States
Loma Linda University Hospital — Loma Linda, California, United States
VA Loma Linda Healthcare System — Loma Linda, California, United States
University of California - San Francisco — San Francisco, California, United States
Orthopedic Pain Specialists — Santa Monica, California, United States
Summit Pain Alliance Inc. — Santa Rosa, California, United States
Pacific Research Institute — Santa Rosa, California, United States
Front Range Pain Medicine — Fort Collins, Colorado, United States
Coastal Orthopedics & Sports Medicine Southwest FL — Bradenton, Florida, United States
Holy Cross Hospital — Fort Lauderdale, Florida, United States
University of Florida - Department of Anesthesia — Gainesville, Florida, United States
Florida Pain Institute — Merritt Island, Florida, United States
Better Health Clinical Research — Newnan, Georgia, United States
Rush University Medical Center — Chicago, Illinois, United States
Goodman Campbell Brain & Spine — Indianapolis, Indiana, United States
Kansas University Medical Center — Kansas City, Kansas, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
Nura — Edina, Minnesota, United States
Twin Cities Pain Clinic — Edina, Minnesota, United States
Advanced Pain Care — Henderson, Nevada, United States
Nevada Advanced Pain Specialists — Reno, Nevada, United States
Ainsworth Institute of Pain Management — New York, New York, United States
The Spine & Pain Institute of New York — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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