TARGET Post-Approval Study

Complex Regional Pain Syndrome (CRPS) Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02800863
• Other study ID #: SJM-CIP-10113
• Status: Active, not recruiting
• Start date: August 23, 2016
• Est. completion date: July 2022

Study information

• Verified date: April 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 426
• Est. completion date: July 2022
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome (CRPS)
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy

Intervention

Device:
• Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
• Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.

Locations

Country	Name	City	State
United States	Premier Pain Solutions	Asheville	North Carolina
United States	St. Luke's Hospital & Health Network	Bethlehem	Pennsylvania
United States	Coastal Orthopedics & Sports Medicine Southwest FL	Bradenton	Florida
United States	Spanish Hills Interventional Pain Specialists	Camarillo	California
United States	The Spine and Nerve Center of St. Francis	Charleston	West Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Adena Bone and Joint Center	Chillicothe	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Nura	Edina	Minnesota
United States	Twin Cities Pain Clinic	Edina	Minnesota
United States	Pacific Sports and Spine	Eugene	Oregon
United States	Center for Intervetional Pain and Spine	Exton	Pennsylvania
United States	Front Range Pain Medicine	Fort Collins	Colorado
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Vertex Spine and Pain	Franklin	Tennessee
United States	University of Florida - Department of Anesthesia	Gainesville	Florida
United States	Advanced Pain Management	Greenfield	Wisconsin
United States	Carolinas Center for Advanced Management of Pain	Greenville	South Carolina
United States	Advanced Pain Care	Henderson	Nevada
United States	Goodman Campbell Brain & Spine	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Central Texas Pain Institute	Killeen	Texas
United States	Dr. Jeffery James Rowe	King Of Prussia	Pennsylvania
United States	California Orthopedics & Spine	Larkspur	California
United States	Loma Linda University Hospital	Loma Linda	California
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Florida Pain Institute	Merritt Island	Florida
United States	Advanced Pain Solutions	Mesquite	Texas
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Better Health Clinical Research	Newnan	Georgia
United States	Thomas Jefferson Department of Neurosurgery	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Nevada Advanced Pain Specialists	Reno	Nevada
United States	Shannon Clinic	San Angelo	Texas
United States	University of California - San Francisco	San Francisco	California
United States	Orthopedic Pain Specialists	Santa Monica	California
United States	Jason Edward Pope, MD LLC	Santa Rosa	California
United States	Summit Pain Alliance Inc.	Santa Rosa	California
United States	Arizona Pain Specialists	Scottsdale	Arizona
United States	Pain Diagnostics and Interventional Care	Sewickley	Pennsylvania
United States	The Spine & Pain Institute of New York	Staten Island	New York
United States	Spinal Diagnostics	Tualatin	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Serious Adverse Events (SAEs)		throughout 12 month study
Secondary	Percent change from baseline to 12 months post-permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS)		12 months
Secondary	Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS Physical Function Scale		12 months
Secondary	Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale		12 months