MedTrace Logo

The Intracept Global Registry ( TIGR ) - Pilot Study

NCT04449835 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-01-05

No results posted yet for this study

Summary

The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.

Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.

Conditions

  • Low Back Pain

Interventions

PROCEDURE

Intracept Procedure

radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain

Sponsors & Collaborators

  • M Squared Associates, Inc.

    collaborator INDUSTRY

  • Relievant Medsystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Zachary McCormick, MD, FAAPMR · Spine and Pain Medicine, University of Utah School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • United States

Study Locations

More Related Trials

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 NCT04449835 on ClinicalTrials.gov