TARGET Post-Approval Study



Status:Recruiting
Conditions:Chronic Pain, Orthopedic, Pain
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:22 - 75
Updated:3/1/2019
Start Date:July 2016
End Date:September 2020
Contact:Todd Stirman
Email:Todd.stirman@Abbott.com
Phone:9725269625

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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

The purpose of this prospective, multicenter, single arm 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.

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.

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.
We found this trial at
46
sites
3865 Childress Avenue
Mesquite, Texas 75150
Principal Investigator: Nagaraj Kikkeri, MD
Phone: 972-681-7246
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Paul Wu, MD
Phone: 954-229-7965
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Fort Lauderdale, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Ahmed Raslan, MD
Phone: 503-494-0407
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Alexios Carayannopoulos, MD
Phone: 401-606-8388
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1091 Hendersonville Road
Asheville, North Carolina 28803
Principal Investigator: Javid Baksh, MD
Phone: 828-712-7689
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
Principal Investigator: Farooq Qureshi, MD
Phone: 484-526-7825
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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6015 Pointe West Boulevard West
Bradenton, Florida 34209
Principal Investigator: Gennady Gekht, MD
Phone: 941-782-1353
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1100 Paseo Camarillo
Camarillo, California 93010
Principal Investigator: Patrick Buchanan, MD
Phone: 805-484-8552
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333 Laidley Street
Charleston, West Virginia 25301
Principal Investigator: Nicholas Bremer, MD
Phone: 304-347-6144
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Timothy Lubenow, MD
Phone: 312-942-2741
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chillicothe, Ohio 45601
Principal Investigator: Mark Malinowski, MD
Phone: 740-649-6908
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Nandan Lad, MD
Phone: 919-681-9997
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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El Paso, Texas 79903
Principal Investigator: Anthony Han, MD
Phone: 915-258-4333
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477 North El Camino Real
Encinitas, California 92024
Principal Investigator: Nathan Perrizo, DO
Phone: 760-941-2600
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Eugene, Oregon 97401
Principal Investigator: Gregory Moore, MD
Phone: 541-284-0530
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Fort Collins, Colorado 80528
Principal Investigator: George Girardi, MD
Phone: 970-495-0506
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Franklin, Tennessee 37067
Principal Investigator: Matthew Rupert, MS
Phone: 615-305-3700
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1600 Southwest Archer Road
Gainesville, Florida 32610
Principal Investigator: Rene Przkora, MD
Phone: 352-273-9096
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Greenfield, Wisconsin 53221
Principal Investigator: Thomas Stauss, MD
Phone: 414-325-3724
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Greenville, South Carolina 29615
Principal Investigator: Kelby Hutcheson, MD
Phone: 864-764-1570
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Henderson, Nevada 89052
Principal Investigator: Michael Fishell, MD
Phone: 702-932-0606
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102 Wessington Place
Hendersonville, Tennessee 37075
Principal Investigator: Peter Kroll, MD
Phone: 615-305-3700
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Indianapolis, Indiana 46202
Principal Investigator: Derron Wilson, MD
Phone: 317-396-1354
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Kansas City, Kansas
Principal Investigator: Dawood Sayed, MD
Phone: 913-945-7420
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1201 Dairy Ashford Road
Katy, Texas 77450
Principal Investigator: Ioannis Skaribas, MD
Phone: 713-458-4530
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700 South Henderson Road
King Of Prussia, Pennsylvania 19406
Principal Investigator: Jeffery Rowe, MD
Phone: 856-534-9165
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Larkspur, California 94939
Principal Investigator: Ramana Naidu, MD
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Loma Linda, California 92357
Principal Investigator: Thomas Edell, MD
Phone: 909-583-6361
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Loma Linda, California 92354
Principal Investigator: Scott Strum, MD
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Merritt Island, Florida 32953
Principal Investigator: Michael Esposito, MD
Phone: 321-784-8211
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Maged Guirguis, MD
Phone: 504-894-2862
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10022
Principal Investigator: Corey Hunter, MD
Phone: 212-203-2813
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111 South 11th Street
Philadelphia, Pennsylvania 19107
Principal Investigator: Ashwini Sharan, MD
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Pittsburgh, Pennsylvania 15236
Principal Investigator: Yeshvant Navalgund, MD
Phone: 412-407-3675
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320 East North Avenue
Pittsburgh, Pennsylvania 15212
Phone: 412-359-3239
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5578 Longley Lane
Reno, Nevada 89511
Principal Investigator: Denis Patterson, DO
Phone: 775-284-8650
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102 North Magdalen Street
San Angelo, Texas 76903
Principal Investigator: Luis Duarte, MD
Phone: 325-481-2131
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San Francisco, California 94143
Principal Investigator: Lawrence Poree, MD
Phone: 415-827-1605
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Santa Monica, California 90403
Principal Investigator: Timothy Davis, MD
Phone: 310-574-2777
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Santa Rosa, California 95401
Principal Investigator: Jason Pope, MD
Phone: 707-623-9803
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Santa Rosa, California 95403
Phone: 707-314-0990
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Scottsdale, Arizona 85258
Principal Investigator: Jon Carlson, MD
Phone: 480-245-6138
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301 Ohio River Boulevard
Sewickley, Pennsylvania 15143
Principal Investigator: David Provenzano, MD
Phone: 412-221-7640
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170 Avenue of the Common
Shrewsbury, New Jersey 07702
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6464 Southwest Borland Road
Tualatin, Oregon 97062
Principal Investigator: Robert Heros, MD
Phone: 503-486-7290
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Winston-Salem, North Carolina 27103
Principal Investigator: Leonardo Kapural, MD
Phone: 336-765-6181
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