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TARGET Post-Approval Study (TARGET PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800863
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief 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.

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)

Detailed Description:
A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.
Study Design
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Study Type : Observational
Actual Enrollment : 426 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Serious Adverse Events (SAEs) [ Time Frame: throughout 12 month study ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS Physical Function Scale [ Time Frame: 12 months ]
  3. Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale [ Time Frame: 12 months ]

Eligibility Criteria
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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
Study Population
Adult subjects aged 22 to 75 with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II with a baseline VAS score of 6 or greater.
Criteria

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 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.

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Show Show 45 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Ann Jannu, PhD, CCRP Abbott Neuromodulation
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02800863    
Other Study ID Numbers: SJM-CIP-10113
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases