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TARGET Post-Approval Study (TARGET PAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02800863
First received: June 7, 2016
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

Condition Intervention
Complex Regional Pain Syndrome (CRPS)
Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 376
Study Start Date: July 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dorsal Root Ganglion (DRG) Stimulation Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System

Detailed Description:
A maximum of 376 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 Neurostimulator System across 40 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.
  Eligibility

Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
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 previously failed (i.e. did not receive > 50% pain relief) spinal cord stimulation.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02800863

Contacts
Contact: Stephanie N Washburn, PhD 9725264810 swashburn@sjm.com

Locations
United States, Arizona
Arizona Pain Specialists Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Ted Swing, PhD    480-245-6138    TedS@arizonapain.com   
Principal Investigator: Jon Carlson, MD         
United States, California
Summit Pain Alliance Inc. Recruiting
Santa Rosa, California, United States, 95401
Contact: Leny Engman    707-623-9803      
Principal Investigator: Jason Pope, MD         
United States, Colorado
Front Range Pain Medicine Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Charleen Wiley    970-495-0506      
Principal Investigator: George Girardi, MD         
United States, Florida
Florida Pain Institute Recruiting
Merritt Island, Florida, United States, 32953
Contact: Susan Clark    321-784-8211 ext 1125    susanclarkflp@gmail.com   
Principal Investigator: Michael Esposito, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Sherry Robinson, MBA    312-942-2985    Sherry_J_Robison@rush.edu   
Principal Investigator: Timothy Lubenow, MD         
United States, Indiana
Goodman Campbell Brain & Spine Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Stacie Gren, RN,BSN    317-396-1354    sgren@goodmancampbell.com   
Principal Investigator: Derron Wilson, MD         
United States, Nevada
Advanced Pain Care Recruiting
Henderson, Nevada, United States, 89052
Contact: Vanessa Pamblanco    702-932-0606      
Principal Investigator: Michael Fishell, MD         
United States, New York
Ainsworth Institute of Pain Management Recruiting
New York, New York, United States, 10022
Contact: Lisa Molina    212-203-2813      
Principal Investigator: Corey Hunter, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Promila Pagadala, PhD    919-681-9997    p.pagadala@duke.edu   
Principal Investigator: Nandan Lad, MD         
Center for Clinical Research, LLC Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Whitney Thompson    336-765-6181    wthompson@ccrpain.com   
Principal Investigator: Leonardo Kapural, MD         
United States, Pennsylvania
St. Luke's Hospital & Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Leah Bryant    484-892-2981      
Principal Investigator: Steven Falowski, MD         
DNA Advanced Pain Treatment Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Contact: Amy Schleifer    412-407-3675      
Principal Investigator: Yeshvant Navalgund, MD         
United States, South Carolina
Carolinas Center for Advanced Management of Pain Recruiting
Greenville, South Carolina, United States, 29615
Contact: Kim Williams    864-764-1570    kimw2685@gmail.com   
Principal Investigator: Kelby Hutcheson, MD         
United States, Texas
El Paso Pain Center Recruiting
El Paso, Texas, United States, 79903
Contact: Marisol Serrana    915-258-4333    marisolserrano.eppc@gmail.com   
Principal Investigator: Anthony Han, MD         
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02800863     History of Changes
Other Study ID Numbers: SJM-CIP-10113 
Study First Received: June 7, 2016
Last Updated: November 30, 2016

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on January 19, 2017