TARGET Post-Approval Study (TARGET PAS)

• ClinicalTrials.gov Identifier: NCT02800863
• Recruitment Status: Active, not recruiting
• First Posted: June 15, 2016
• Last Update Posted: February 23, 2021
• Sponsor: Abbott Medical Devices
• 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: February 23, 2021
• Actual Study Start Date: August 23, 2016
• Estimated Primary Completion Date: March 2022 (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

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 17, 2019): 426
• Original Estimated Enrollment (submitted: June 14, 2016): 376
• Estimated Study Completion Date: September 2022
• Estimated Primary Completion Date: March 2022 (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 information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

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: February 2021