INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
NCT ID: NCT03246061
Last Updated: 2024-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2017-08-24
2024-03-05
Brief Summary
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The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
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Detailed Description
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Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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BVN Ablation
BVN ablation with continued standard care
Intracept System
BVN ablation using radiofrequency energy
Standard Care Control
Continue with non-surgical standard care
Standard Care
Non-surgical standard care
Interventions
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Intracept System
BVN ablation using radiofrequency energy
Standard Care
Non-surgical standard care
Eligibility Criteria
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Inclusion Criteria
* Chronic lower back pain for at least 6 months
* Failure to respond to at least 6 months of non-operative conservative management
Exclusion Criteria
* 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
25 Years
70 Years
ALL
No
Sponsors
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Relievant Medsystems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steven R Garfin, MD
Role: PRINCIPAL_INVESTIGATOR
Independent
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Barrow Brain and Spine
Phoenix, Arizona, United States
Keck Medicine of USC
Los Angeles, California, United States
Stanford Orthopaedic Surgery
Redwood City, California, United States
Denver Back Specialists
Greenwood Village, Colorado, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Beaumont Hospital
Royal Oak, Michigan, United States
St Luke's Hospital
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Bassett Medical Center
Cooperstown, New York, United States
University of Rochester
Rochester, New York, United States
OrthoCarolina
Charlotte, North Carolina, United States
Clinical Investigations
Edmond, Oklahoma, United States
Pacific Sports and Spine
Eugene, Oregon, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Precision Spine Center
Tyler, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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INTRACEPT Study Website
Other Identifiers
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CIP 0006
Identifier Type: -
Identifier Source: org_study_id
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