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Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

NCT03997825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2021-01-13

Study results available
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Summary

The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

Basivertebral Nerve (BVN) Ablation

Single follow-up visit of previously treated participants from the SMART trial.

Sponsors & Collaborators

  • Relievant Medsystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Fischgrund, MD · William Beaumont Hospitals

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2019-11-08
Completion
2019-11-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997825 on ClinicalTrials.gov