MedDataX Logo

Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

NCT ID: NCT03266107

Last Updated: 2020-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2020-02-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Vertebrogenic Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

BVN Ablation

Group Type EXPERIMENTAL

Intracept

Intervention Type DEVICE

Radiofrequency ablation of the basivertebral nerve using the Intracept System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intracept

Radiofrequency ablation of the basivertebral nerve using the Intracept System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Skeletally mature subjects at least 25 years of age
* Chronic low back pain for at least 6 months
* Failure to respond to at least 6 months of non-operative conservative management
* Oswestry Disability Index (ODI) at least 30 points
* Modic changes Type 1 or 2

Exclusion Criteria

* Current or history of vertebral cancer or spinal metastasis
* History of a fragility fracture
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Disc extrusion or protrusion
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Relievant Medsystems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eeric Truumees, MD

Role: PRINCIPAL_INVESTIGATOR

Independent

Kevin Macadaeg, MD

Role: PRINCIPAL_INVESTIGATOR

Independent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana Spine Group

Carmel, Indiana, United States

Site Status

Seton Spine and Scoliosis Center

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIP 0007 and CIP 0008

Identifier Type: -

Identifier Source: org_study_id