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 |
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.
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.
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
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 727-5640
Phone: 404-778-7881
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
Click here to add this to my saved trials
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Click here to add this to my saved trials
Birmingham, Alabama 35235
Principal Investigator: Brad Goodman, MD
Phone: 205-833-2228
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Davis, California 95816
Principal Investigator: Eric Klineberg, MD
Phone: 916-734-3093
Click here to add this to my saved trials
Click here to add this to my saved trials
140 North Litchfield Road
Goodyear, Arizona 85338
Goodyear, Arizona 85338
Principal Investigator: Daniel Lieberman, MD
Phone: 602-256-2525
Click here to add this to my saved trials
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
Click here to add this to my saved trials
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Los Angeles, California 90048
Principal Investigator: Neel Anand, MD
Phone: 310-423-9779
Click here to add this to my saved trials
1801 N Broad St
Philadelphia, Pennsylvania 19122
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
2737 South Broadway Avenue
Tyler, Texas 75701
Tyler, Texas 75701
Principal Investigator: Aaron Calodney, MD
Phone: 903-531-0566
Click here to add this to my saved trials