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
Status: Active, not recruiting
Location: See all (45) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: No
View:
• 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.
Locations
United States
Arizona
Arizona Pain Specialists
Scottsdale
California
Spanish Hills Interventional Pain Specialists
Camarillo
California Orthopedics & Spine
Larkspur
Loma Linda University Hospital
Loma Linda
VA Loma Linda Healthcare System
Loma Linda
University of California - San Francisco
San Francisco
Orthopedic Pain Specialists
Santa Monica
Jason Edward Pope, MD LLC
Santa Rosa
Summit Pain Alliance Inc.
Santa Rosa
Colorado
Front Range Pain Medicine
Fort Collins
Florida
Coastal Orthopedics & Sports Medicine Southwest FL
Bradenton
Holy Cross Hospital
Fort Lauderdale
University of Florida - Department of Anesthesia
Gainesville
Florida Pain Institute
Merritt Island
Georgia
Better Health Clinical Research
Newnan
Illinois
Rush University Medical Center
Chicago
Indiana
Goodman Campbell Brain & Spine
Indianapolis
Kansas
Kansas University Medical Center
Kansas City
Louisiana
Ochsner Medical Center
New Orleans
Minnesota
Nura
Edina
Twin Cities Pain Clinic
Edina
North Carolina
Premier Pain Solutions
Asheville
Duke University Medical Center
Durham
Nevada
Advanced Pain Care
Henderson
Nevada Advanced Pain Specialists
Reno
New York
Ainsworth Institute of Pain Management
New York
The Spine & Pain Institute of New York
Staten Island
Ohio
Adena Bone and Joint Center
Chillicothe
The Cleveland Clinic
Cleveland
Oregon
Pacific Sports and Spine
Eugene
Oregon Health & Science University
Portland
Spinal Diagnostics
Tualatin
Pennsylvania
St. Luke's Hospital & Health Network
Bethlehem
Center for Intervetional Pain and Spine
Exton
Dr. Jeffery James Rowe
King Of Prussia
Thomas Jefferson Department of Neurosurgery
Philadelphia
Pain Diagnostics and Interventional Care
Sewickley
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Carolinas Center for Advanced Management of Pain
Greenville
Tennessee
Vertex Spine and Pain
Franklin
Texas
Central Texas Pain Institute
Killeen
Advanced Pain Solutions
Mesquite
Shannon Clinic
San Angelo
Wisconsin
Advanced Pain Management
Greenfield
West Virginia
The Spine and Nerve Center of St. Francis
Charleston
Time Frame
Start Date: August 23, 2016
Estimated Completion Date: July 2022
Participants
Target number of participants: 426
Treatments
Dorsal Root Ganglion (DRG) Stimulation
Authors
Yeshvant Navalgund, Jeffery Rowe, John Mak, Anthony Han, Steven Falowski, John Hau, Jon Carlson, Ioannis Skaribas, Gennady Gekht, Pankaj Mehta, Peter Staats, Muhammad Zulqarnain, Robert Bolash, Ashish Udeshi, Chengyuan Wu, Jeremy Adler, Michael Yang, David Schultz, Nathan Harrison, Gassan Chaiban, Nagaraj Kikkeri, Kimberly Bryant, Michael Fishell, Daniel Fung, Luis Duarte, David Provenzano, Asokumar Buvanendran, Matthew Rupert, Maged Guirguis, Gregory Moore, Lawrence Poree, Timothy Lubenow, Dale Kiker, Michael Brown, Timothy Davis, Mark Malinowski, Ashwini Sharan, Denis Patterson, Nathan Perrizo, Jason Pope, Lawrence Owusu, Michael Davis, Patrick Buchanan, Peter Kroll, Michael Esposito, Farooq Qureshi, Paul Wu, Nicholas Bremer, Thomas Stauss, Kenneth Chapman, Chong H Kim, George Girardi, Ramana Naidu, Javid Baksh, Scott Strum, Andrew Will, Robert Heros, Jonathan Riley, Thomas Edell, Dawood Sayed, Rene Przkora, Ali Nairizi, Corey Hunter, Charles Brownlow, Derron Wilson, Ahmed Raslan, Christopher Gilmore, Alexios Carayannopoulos, Joan Priddy-Southern, Runyon Scott, Kelby Hutcheson, Baksh Javid, Leonardo Kapural, Nandan Lad
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices