Minimally-invasive procedure for vertebrogenic back pain
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Boston Scientific Corporation · NCT06827262
This study looks at how well the Intracept™ procedure works for people with chronic low-back pain caused by vertebrogenic issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation (industry) |
| Locations | 16 sites (Flagstaff, Arizona and 15 other locations) |
| Trial ID | NCT06827262 on ClinicalTrials.gov |
What this trial studies
This study compiles real-world outcomes from patients treated with the Intracept™ Intraosseous Nerve Ablation System for vertebrogenic pain. It focuses on chronic low-back pain and aims to gather data on the effectiveness of this commercially approved treatment. By observing patients scheduled for this procedure, the study seeks to provide insights into its real-world application and outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with vertebrogenic pain who are scheduled for treatment with the Intracept™ system.
Not a fit: Patients who have contraindications as per the Instructions for Use of the Intracept™ system may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide patients with a minimally invasive option for managing chronic low-back pain effectively.
How similar studies have performed: Other studies have shown promising results with similar minimally invasive approaches for chronic low-back pain, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Flagstaff, Arizona and 15 other locations
- Flagstaff Bone & Joint — Flagstaff, Arizona, United States (RECRUITING)
- Innovative Pain and Wellness — Phoenix, Arizona, United States (RECRUITING)
- MarinHealth Spine Institute — Larkspur, California, United States (RECRUITING)
- The Spine Wellness Center in Westport — Westport, Connecticut, United States (RECRUITING)
- Washington Hospital Center — Washington D.C., District of Columbia, United States (RECRUITING)
- North Idaho Day Surgery, LLC — Post Falls, Idaho, United States (RECRUITING)
- Illinois Bone and Joint Institute — Barrington, Illinois, United States (RECRUITING)
- Commonwealth Pain and Spine — Lexington, Kentucky, United States (RECRUITING)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (RECRUITING)
- iSpine Clinics — Maple Grove, Minnesota, United States (RECRUITING)
- New York Spine and Pain Specialists — Port Jefferson Station, New York, United States (RECRUITING)
- University of Rochester — Rochester, New York, United States (RECRUITING)
- Novant Health Spine Specialists — Bermuda Run, North Carolina, United States (RECRUITING)
- Pacific Sports and Spine — Eugene, Oregon, United States (ACTIVE_NOT_RECRUITING)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Utah Orthopaedic Center — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Ann Yamano
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Low-back Pain, Vertebrogenic Pain Syndrome, Intraosseous basivertebral nerve ablation, Axial low back pain, Low Back Pain