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Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

NCT ID: NCT06827262

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-26

Study Completion Date

2034-07-31

Brief Summary

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

Detailed Description

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The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Conditions

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Chronic Low-back Pain Vertebrogenic Pain Syndrome

Keywords

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Intraosseous basivertebral nerve ablation Axial low back pain Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intracept™ Intraosseous Nerve Ablation Systems

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

Intracept™ Intraosseous Nerve Ablation

Intervention Type DEVICE

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

Interventions

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Intracept™ Intraosseous Nerve Ablation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Meets any contraindications per locally applicable Instructions for Use (IFU).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons, M.A.

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Flagstaff Bone & Joint

Flagstaff, Arizona, United States

Site Status RECRUITING

MarinHealth Spine Institute

Larkspur, California, United States

Site Status RECRUITING

The Spine Wellness Center in Westport

Westport, Connecticut, United States

Site Status RECRUITING

Washington Hospital Center

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

Site Status RECRUITING

North Idaho Day Surgery, LLC

Post Falls, Idaho, United States

Site Status RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status RECRUITING

iSpine Clinics

Maple Grove, Minnesota, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Pacific Sports and Spine

Eugene, Oregon, United States

Site Status RECRUITING

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ann Yamano

Role: CONTACT

Phone: 855-213-9890

Email: [email protected]

Diane Keesey

Role: CONTACT

Phone: 855-213-9890

Email: [email protected]

Facility Contacts

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Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Boston Scientific Clinical Research

Role: primary

Other Identifiers

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REL025

Identifier Type: -

Identifier Source: org_study_id