Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain (CLBP)

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• Status: Withdrawn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: Chronic Low Back Pain
• Intervention / Treatment: Device: Intracept System Ablation

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

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 68 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracept System Ablation	Device: Intracept System Ablation; Radiofrequency ablation using Intracept System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	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)	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)	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

• Sponsor: Relievant Medsystems, Inc.
• Investigators: Principal Investigator: Isador Lieberman, MD, Texas Back Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): July 12, 2019
• Study Completion (Anticipated): July 12, 2020

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIP 0009

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