- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630133
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP)
June 16, 2020 updated by: Relievant Medsystems, Inc.
A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, open-label, single-arm, single-center study.
There is no randomization or blinding.
Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Carmel, Indiana, United States, 46032
- Indiana Spine Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Skeletally mature subjects age 25-70 years, inclusive
- Chronic lower back pain for at least six months
- Failure to respond to at least six months of non-operative conservative management
- Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
- Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1
Exclusion Criteria:
- Radicular pain by history or evidence of pain neurological deficit within the past one year.
- Previous surgery performed on the lumbar spine
- Current or history of symptomatic spinal stenosis
- Current or history of osteoporotic or tumor-related vertebral body compression fracture
- Current or history of vertebral cancer or spinal metastasis
- Current or history of spinal infection
- Metabolic bone disease
- BMI greater or equal to 40
- Any radiographic evidence of other important back pathology
- MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
- Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- Subjects who are bed bound
- Demonstrates 3 or more Waddell's signs of Inorganic Behavior
- Any evidence of current systemic infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intracept System Ablation
Single Arm
|
Radiofrequency ablation using Intracept System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index (ODI)
Time Frame: 3 months
|
Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment.
Scale is measured from 0 to 100, better to worse respectively.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 3, 6, 9, and 12 months
|
Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment.
Scale is measured from 0 to 10, better to worse respectively.
|
3, 6, 9, and 12 months
|
Oswestry Disability Index (ODI)
Time Frame: 6, 9, and 12 months
|
Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment.
Scale is measured from 0 to 100, better to worse respectively.
|
6, 9, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin Macadaeg, MD, Indiana Spine Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2018
Primary Completion (Actual)
February 29, 2020
Study Completion (Actual)
February 29, 2020
Study Registration Dates
First Submitted
August 9, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 14, 2018
Study Record Updates
Last Update Posted (Actual)
June 17, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP 0008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
At the completion of trial
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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