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

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ClinicalTrials.gov Identifier: NCT03246061
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Relievant Medsystems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Intracept System Other: Non-surgical conservative therapies Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: RF Ablation arm vs Control arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: RF Ablation
RF ablation with non-surgical management therapies
Device: Intracept System
RF ablation

Active Comparator: Control
Continue with non-surgical management therapies
Other: Non-surgical conservative therapies
Conservative therapies




Primary Outcome Measures :
  1. mean change from baseline to 3 months post-treatment in the Oswestry Disability Index (ODI) [ Time Frame: 3 months ]
    Evaluated in both the treatment and control groups



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246061


Contacts
Contact: Thuy Olender 650-368-1000 tolender@relievant.com
Contact: Matt Kraemer 650-368-1000 mkraemer@relievant.com

Locations
United States, Alabama
Alabama Clinical Therapeutics Recruiting
Birmingham, Alabama, United States, 35235
Contact: Jill Andringa, RN    205-833-2228    jill.andringa@actstudy.net   
Principal Investigator: Brad Goodman, MD         
United States, Arizona
Phoenix Spine Center Recruiting
Goodyear, Arizona, United States, 85338
Contact: Deb Swaton, RN    602-256-2525 ext 203    deb@phxspine.com   
Principal Investigator: Daniel Lieberman, MD         
United States, California
UC Davis Spine Center Not yet recruiting
Davis, California, United States, 95816
Contact: Abhijeet Gorhe    916-734-3093    asgorhe@ucdavis.edu   
Principal Investigator: Eric Klineberg, MD         
Sub-Investigator: Samir Sheth, MD         
Keck Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Marianna Ovnatanian    323-865-6916    Marianna.Ovnatanian@med.usc.edu   
Cedars Sinai Spine Center Recruiting
Los Angeles, California, United States, 90048
Contact: Babak Khandehroo    310-423-9779    babak.khandehroo@cshs.org   
Principal Investigator: Neel Anand, MD         
Sub-Investigator: Evish Kamrava, MD         
Stanford Orthopaedic Surgery Recruiting
Redwood City, California, United States, 94063
Contact: Stanford Orthopaedic Surgery         
United States, Colorado
Denver Back Specialists Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Denver Back Specialist         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: Tiffany Dumas    404-778-7881    tiffany.n.dumas@emory.edu   
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Rush University         
United States, Michigan
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Lisa Motowski, BSN    248-551-6679    Lisa.Motowski@beaumont.org   
United States, Missouri
St Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: St Luke's Hospital St Luke's Hospital         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Aria Elahi    203-298-2225    Aria.Elahi@hitchcock.org   
United States, New York
Bassett Medical Center Recruiting
Cooperstown, New York, United States, 13326
Contact: Jennifer Victory, RN    607-547-6965    jennifer.victory@bassett.org   
University of Rochester Recruiting
Rochester, New York, United States, 14618
Contact: University of Rochester University of Rochester         
United States, Oklahoma
Clinical Investigations Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Clinical Investigations         
United States, Pennsylvania
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Penn State Milton S Hershey Medical Center         
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19147
Contact: Kathleen Hatala    215-707-4171    kathleen.hatala@tuhs.temple.edu   
Principal Investigator: Charles Munyon, MD         
United States, Texas
Precision Spine Center Recruiting
Tyler, Texas, United States, 75701
Contact: Jeanetta Patterson, RN    903-531-0566    jeanettap@psctyler.com   
Principal Investigator: Aaron Calodney, MD         
Sponsors and Collaborators
Relievant Medsystems, Inc.
Investigators
Principal Investigator: Steven R Garfin, MD Independent

Additional Information:
Responsible Party: Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier: NCT03246061     History of Changes
Other Study ID Numbers: CIP 0006
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Trial results will be published at the completion of the trial
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: End of trial
Access Criteria: To be determined

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms