TARGET Post-Approval Study
TARGET PAS
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
1 other identifier
observational
426
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedStudy Start
First participant enrolled
August 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2021
CompletedResults Posted
Study results publicly available
July 8, 2024
CompletedJuly 8, 2024
January 1, 2024
5.1 years
June 7, 2016
November 8, 2022
January 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Serious Adverse Events (SAEs)
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
throughout 12 month study
Secondary Outcomes (3)
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)
12 months
Change From Baseline to 12 Months Post-permanent Implant for Physical Function Measured Using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Physical Function Scale
12 months
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
12 months
Study Arms (1)
Dorsal Root Ganglion (DRG) Stimulation
Interventions
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
Eligibility Criteria
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.
You may qualify if:
- 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 Visual Analogue Scale (VAS) 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Arizona Pain Specialists
Scottsdale, Arizona, 85258, United States
Spanish Hills Interventional Pain Specialists
Camarillo, California, 93010, United States
California Orthopedics & Spine
Larkspur, California, 94939, United States
Loma Linda University Hospital
Loma Linda, California, 92354, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
University of California - San Francisco
San Francisco, California, 94143, United States
Orthopedic Pain Specialists
Santa Monica, California, 90403, United States
Summit Pain Alliance Inc.
Santa Rosa, California, 95401, United States
Pacific Research Institute
Santa Rosa, California, 95403, United States
Front Range Pain Medicine
Fort Collins, Colorado, 80525, United States
Coastal Orthopedics & Sports Medicine Southwest FL
Bradenton, Florida, 34209, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
University of Florida - Department of Anesthesia
Gainesville, Florida, 32610, United States
Florida Pain Institute
Merritt Island, Florida, 32953, United States
Better Health Clinical Research
Newnan, Georgia, 30265, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Goodman Campbell Brain & Spine
Indianapolis, Indiana, 46260, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Nura
Edina, Minnesota, 55435, United States
Twin Cities Pain Clinic
Edina, Minnesota, 55439, United States
Advanced Pain Care
Henderson, Nevada, 89052, United States
Nevada Advanced Pain Specialists
Reno, Nevada, 89511, United States
Ainsworth Institute of Pain Management
New York, New York, 10022, United States
The Spine & Pain Institute of New York
Staten Island, New York, 10305, United States
Premier Pain Solutions
Asheville, North Carolina, 28803, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Adena Bone and Joint Center
Chillicothe, Ohio, 45601, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Pacific Sports and Spine
Eugene, Oregon, 97404, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Spinal Diagnostics
Tualatin, Oregon, 97062, United States
Center for Intervetional Pain and Spine
Exton, Pennsylvania, 19341, United States
Main Line Spine
King of Prussia, Pennsylvania, 19406, United States
Thomas Jefferson Department of Neurosurgery
Philadelphia, Pennsylvania, 19107, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Carolinas Center for Advanced Management of Pain
Greenville, South Carolina, 29615, United States
Vertex Spine and Pain
Franklin, Tennessee, 37067, United States
Central Texas Pain Institute
Killeen, Texas, 76542, United States
Advanced Pain Solutions
Mesquite, Texas, 75150, United States
Shannon Clinic
San Angelo, Texas, 76903, United States
The Spine and Nerve Center of St. Francis
Charleston, West Virginia, 25301, United States
Advanced Pain Management
Greenfield, Wisconsin, 53221, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nicole Harbert
- Organization
- Abbott Vascular
Study Officials
- STUDY DIRECTOR
Ann Jannu, PhD, CCRP
Abbott Neuromodulation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2016
First Posted
June 15, 2016
Study Start
August 23, 2016
Primary Completion
September 23, 2021
Study Completion
September 23, 2021
Last Updated
July 8, 2024
Results First Posted
July 8, 2024
Record last verified: 2024-01