Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

NCT03630133 | Withdrawn FDA Device

• 1 other identifier: CIP 0008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Scale (VAS)

  3, 6, 9, and 12 months

• Oswestry Disability Index (ODI)

  6, 9, and 12 months

Study Arms (1)

Intracept System Ablation

EXPERIMENTAL

Single Arm

Device: Intracept System Ablation

Interventions

Intracept System Ablation DEVICE

Radiofrequency ablation using Intracept System

Intracept System Ablation

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Relievant Medsystems, Inc.: lead

Study Sites (1)

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Study Officials

• Kevin Macadaeg, MD

  Indiana Spine Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: May 8, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: At the completion of trial

Locations

US (1)