INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP

NCT03246061 | Completed Results FDA Device

• 1 other identifier: CIP 0006
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 18

Brief Summary

Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment. The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)

  Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a 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 for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.

  3 months

Secondary Outcomes (1)

• Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)

  3 months post treatment / randomization

Study Arms (2)

BVN Ablation

ACTIVE COMPARATOR

BVN ablation with continued standard care

Device: Intracept System

Standard Care Control

ACTIVE COMPARATOR

Continue with non-surgical standard care

Other: Standard Care

Interventions

Intracept System DEVICE

BVN ablation using radiofrequency energy

BVN Ablation

Standard Care OTHER

Non-surgical standard care

Standard Care Control

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 lower back pain for at least 6 months
• Failure to respond to at least 6 months of non-operative conservative management

You may not qualify if:

• Radicular pain
• Current or history of spinal infection
• Modic changes at vertebral bodies other than L3 to S1
• Contraindication to MRI
• Pregnant, lactating or plan to become pregnant in next year
• Has life expectancy of less than 2 years
• Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired

Sponsors & Collaborators

• Relievant Medsystems, Inc.: lead

Study Sites (18)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Barrow Brain and Spine

Phoenix, Arizona, 85048, United States

Location

Keck Medicine of USC

Los Angeles, California, 90033, United States

Location

Stanford Orthopaedic Surgery

Redwood City, California, 94063, United States

Location

Denver Back Specialists

Greenwood Village, Colorado, 80111, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Bassett Medical Center

Cooperstown, New York, 13326, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Clinical Investigations

Edmond, Oklahoma, 73013, United States

Location

Pacific Sports and Spine

Eugene, Oregon, 97401, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Temple University

Philadelphia, Pennsylvania, 19147, United States

Location

Precision Spine Center

Tyler, Texas, 75701, United States

Location

Related Links

• INTRACEPT Study Website

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Chris Hilker, Sr. Director Clinical Affairs
• Organization: Relievant Medsystems

chilker@relievant.com

(650) 368-1000

Study Officials

• Steven R Garfin, MD

  Independent

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: BVN Ablation vs Standard Care Control

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: August 24, 2017
• Primary Completion: January 18, 2019
• Study Completion: March 5, 2024
• Last Updated: April 2, 2024
• Results First Posted: December 22, 2020

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: End of trial
• Access Criteria: To be determined

Locations

US (18)