Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800863
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date June 7, 2016
First Posted Date June 15, 2016
Last Update Posted Date October 21, 2019
Study Start Date July 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2016)
Percentage of Serious Adverse Events (SAEs) [ Time Frame: throughout 12 month study ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 14, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TARGET Post-Approval Study
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Complex Regional Pain Syndrome (CRPS)
Intervention
  • 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.
Study Groups/Cohorts Dorsal Root Ganglion (DRG) Stimulation
Interventions:
  • Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
  • Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 17, 2019)
426
Original Estimated Enrollment
 (submitted: June 14, 2016)
376
Estimated Study Completion Date September 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Todd Stirman 9725269625 Todd.stirman@Abbott.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02800863
Other Study ID Numbers SJM-CIP-10113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date October 2019