TARGET Post-Approval Study (TARGET PAS)
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|ClinicalTrials.gov Identifier: NCT02800863|
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : April 7, 2022
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|Condition or disease||Intervention/treatment|
|Complex Regional Pain Syndrome (CRPS)||Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)|
|Study Type :||Observational|
|Actual Enrollment :||426 participants|
|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|
|Actual Study Start Date :||August 23, 2016|
|Actual Primary Completion Date :||September 23, 2021|
|Estimated Study Completion Date :||July 2022|
|Dorsal Root Ganglion (DRG) Stimulation||
Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
- Percentage of Serious Adverse Events (SAEs) [ Time Frame: throughout 12 month study ]
- Percent change from baseline to 12 months post-permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS) [ Time Frame: 12 months ]
- Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS Physical Function Scale [ Time Frame: 12 months ]
- Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale [ Time Frame: 12 months ]
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|Ages Eligible for Study:||22 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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 VAS score 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800863
|Study Director:||Ann Jannu, PhD, CCRP||Abbott Neuromodulation|
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|First Posted:||June 15, 2016 Key Record Dates|
|Last Update Posted:||April 7, 2022|
|Last Verified:||April 2022|
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases