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History of Changes for Study: NCT02800863
TARGET Post-Approval Study (TARGET PAS)
Latest version (submitted April 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 14, 2016 None (earliest Version on record)
2 August 23, 2016 Recruitment Status, Study Design, Study Status, Eligibility, Contacts/Locations, Groups and Interventions and Study Description
3 October 31, 2016 Contacts/Locations and Study Status
4 November 30, 2016 Contacts/Locations and Study Status
5 March 6, 2017 Study Status and Contacts/Locations
6 March 7, 2017 Contacts/Locations and Study Status
7 April 24, 2017 Contacts/Locations and Study Status
8 July 20, 2017 Contacts/Locations and Study Status
9 February 7, 2018 Contacts/Locations, Study Status and Eligibility
10 June 28, 2018 Contacts/Locations and Study Status
11 September 7, 2018 Contacts/Locations and Study Status
12 September 25, 2018 Contacts/Locations and Study Status
13 January 28, 2019 Contacts/Locations, Study Status and Study Identification
14 February 25, 2019 Contacts/Locations and Study Status
15 July 1, 2019 Study Status
16 October 17, 2019 Contacts/Locations, Groups and Interventions, Study Description, Study Status and Study Design
17 February 22, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
18 October 5, 2021 Study Status
19 April 6, 2022 Study Status and Contacts/Locations
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Study NCT02800863
Submitted Date:  June 14, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: SJM-CIP-10113
Brief Title: TARGET Post-Approval Study (TARGET PAS)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2016
Overall Status: Not yet recruiting
Study Start: July 2016
Primary Completion: November 2018 [Anticipated]
Study Completion: May 2019 [Anticipated]
First Submitted: June 7, 2016
First Submitted that
Met QC Criteria:
June 14, 2016
First Posted: June 15, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 14, 2016
Last Update Posted: June 15, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this prospective, multicenter, single arm, observational 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.
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.
Open or close this module Conditions
Conditions: Complex Regional Pain Syndrome (CRPS)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 376 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dorsal Root Ganglion (DRG) Stimulation Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 22 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Stephanie N Washburn, PhD
Telephone: 9725264810
Email: swashburn@sjm.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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