NCT06827262

Brief Summary

Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
98mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2025Jul 2034

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2034

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

9.3 years

First QC Date

February 10, 2025

Last Update Submit

June 3, 2026

Conditions

Chronic Low-back PainVertebrogenic Pain Syndrome

Keywords

Intraosseous basivertebral nerve ablationAxial low back painLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Disability (Oswestry Disability Index (ODI) from Baseline

    The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.

    60-months post-procedure

Study Arms (1)

Intracept™ Intraosseous Nerve Ablation Systems

Subjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System

Device: Intracept™ Intraosseous Nerve Ablation

Interventions

Intracept™ Intraosseous Nerve AblationDEVICE

Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain

Intracept™ Intraosseous Nerve Ablation Systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.

You may qualify if:

  • Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
  • Signed a valid, IRB/EC-approved informed consent form.

You may not qualify if:

  • Meets any contraindications per locally applicable Instructions for Use (IFU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Flagstaff Bone & Joint

Flagstaff, Arizona, 86001, United States

RECRUITING

Innovative Pain and Wellness

Phoenix, Arizona, 85014, United States

RECRUITING

MarinHealth Spine Institute

Larkspur, California, 94939, United States

RECRUITING

The Spine Wellness Center in Westport

Westport, Connecticut, 06880, United States

RECRUITING

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

North Idaho Day Surgery, LLC

Post Falls, Idaho, 83854, United States

RECRUITING

Illinois Bone and Joint Institute

Barrington, Illinois, 60010, United States

RECRUITING

Commonwealth Pain and Spine

Lexington, Kentucky, 40509, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States

RECRUITING

iSpine Clinics

Maple Grove, Minnesota, 55369, United States

RECRUITING

New York Spine and Pain Specialists

Port Jefferson Station, New York, 11776, United States

RECRUITING

University of Rochester

Rochester, New York, 14618, United States

RECRUITING

Novant Health Spine Specialists

Bermuda Run, North Carolina, 27106, United States

RECRUITING

Pacific Sports and Spine

Eugene, Oregon, 97404, United States

ACTIVE NOT RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Cy-Pain and Spine

Houston, Texas, 77065, United States

RECRUITING

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Back PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natalie Bloom Lyons, M.A.

    Boston Scientific Corporation

    STUDY DIRECTOR

Central Study Contacts

Ann Yamano

CONTACT

855-213-9890BSNClinicalTrials@bsci.com

Diane Keesey

CONTACT

855-213-9890BSNClinicalTrials@bsci.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

March 26, 2025

Primary Completion (Estimated)

July 1, 2034

Study Completion (Estimated)

July 1, 2034

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(17)