Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

NCT ID: NCT03658018

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-07-12

Brief Summary

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

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intracept System Ablation

Group Type: EXPERIMENTAL

Intracept System Ablation

Intervention Type: DEVICE

Radiofrequency ablation using Intracept System

Interventions

Intracept System Ablation

Radiofrequency ablation using Intracept System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Relievant Medsystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isador Lieberman, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Back Institute

Locations

Texas Back Institute

Plano, Texas, United States

Countries

United States

Other Identifiers

CIP 0009

Identifier Type: -

Identifier Source: org_study_id