Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:25 - 70
Updated:11/7/2018
Start Date:August 24, 2017
End Date:September 2020
Contact:Thuy Olender
Email:tolender@relievant.com
Phone:650-368-1000

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Trial Summary
Trial Overview
Inclusion Criteria

INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Subjects will be randomized 1:1 Radio Frequency (RF) Ablation arm vs Control arm; this is an
open-label trial. Subjects in the the RF Ablation arm will receive the Intracept System
procedure to treat up to 4 vertebral bodies (L3 to S1). Subjects in the Control arm will
continue on non-surgical management therapies to treat their chronic low back pain (CLBP) and
will be offered optional crossover after 12 months of follow-up.

Subjects in the RF Ablation arm will be followed for 24 months following treatment. RF
Ablation arm subjects will be approached to participate in a sub study of 3 additional years
of follow-up at their 24 month visit. Control arm subjects will be offered optional crossover
treatment after the 12 month follow-up visit and will be followed for an additional 6 months
following crossover.

Inclusion Criteria:

- Skeletally mature subjects at least 25 years of age

- Chronic lower back pain for at least 6 months

- Failure to respond to at least 6 months of non-operative conservative management

Exclusion Criteria:

- Radicular pain

- Current or history of spinal infection

- Modic changes at vertebral bodies other than L3 to S1

- Contraindication to MRI

- Pregnant, lactating or plan to become pregnant in next year

- Has life expectancy of less than 2 years

- Compensated injuries or ongoing litigation regarding back pain/injury, or financial
incentive to remain impaired
We found this trial at
18
sites
Bassett Medical Center
Cooperstown, New York 13326
Phone: 607-547-6965
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Emory University School of Medicine
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Phone: 404-778-7881
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University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Alabama Clinical Therapeutics, Llc
Birmingham, Alabama 35235
Principal Investigator: Brad Goodman, MD
Phone: 205-833-2228
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Rush University
Chicago, Illinois 60612
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UC Davis Spine Center
Davis, California 95816
Principal Investigator: Eric Klineberg, MD
Phone: 916-734-3093
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Davis, CA
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Clinical Investigations, LLC
Edmond, Oklahoma 73013
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Edmond, OK
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Phoenix Spine Center
140 North Litchfield Road
Goodyear, Arizona 85338
Principal Investigator: Daniel Lieberman, MD
Phone: 602-256-2525
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Goodyear, AZ
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Denver Back Specialists
7800 East Orchard Road
Greenwood Village, Colorado 80111
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Greenwood Village, CO
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Penn State Milton S. Hershey Medical Center
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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ST. Luke's Hospital
Kansas City, Missouri 64111
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Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 203-298-2225
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Keck Medicine of USC
Los Angeles, California 90033
Phone: 323-865-6916
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Los Angeles, CA
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Cedars-Sinai Spine Center
Los Angeles, California 90048
Principal Investigator: Neel Anand, MD
Phone: 310-423-9779
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Temple University
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Charles Munyon, MD
Phone: 215-707-4171
Temple University Temple University is many things to many people. A place to pursue life's...
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Stanford Orthopaedic Surgery
450 Broadway
Redwood City, California 94063
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Beaumont Hospital
Royal Oak, Michigan 48073
Phone: 248-551-6679
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Precision Spine Center
2737 South Broadway Avenue
Tyler, Texas 75701
Principal Investigator: Aaron Calodney, MD
Phone: 903-531-0566
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