Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

NCT03266107 | Completed Results FDA Device

• 1 other identifier: CIP 0007 and CIP 0008
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Low Back Pain

Keywords

Vertebrogenic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) - 3 Months

  Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline.

  3 months

Secondary Outcomes (8)

• Visual Analog Scale (VAS) - 3 Months

  3 Months

• ODI Responder Rate - 3-Month

  3 Months

• VAS Responder Rate - 3 Month

  3 Months

• ODI -12 Months

  12 Months

• VAS - 12 Month

  12 Months

Study Arms (1)

Treatment

EXPERIMENTAL

BVN Ablation

Device: Intracept

Interventions

Intracept DEVICE

Radiofrequency ablation of the basivertebral nerve using the Intracept System

Treatment

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Relievant Medsystems, Inc.: lead

Study Sites (2)

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Seton Spine and Scoliosis Center

Austin, Texas, 78731, United States

Location

Results Point of Contact

• Title: VP Clinical Affairs
• Organization: Relievant Medsystems Inc.

dsahr@relievant.com

(650) 368-1000

Study Officials

• Eeric Truumees, MD

  Independent

  PRINCIPAL INVESTIGATOR

• Kevin Macadaeg, MD

  Independent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 16, 2017
• First Posted: August 29, 2017
• Study Start: February 14, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: At the completion of trial
• Access Criteria: Written request to study sponsor

Locations

US (2)