The Intracept Global Registry ( TIGR ) - Pilot Study

Low Back Pain Clinical Trial

Official title: The Intracept Global Registry

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.

Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept. ;

Related Conditions & MeSH terms

• Low Back Pain

• NCT number: NCT04449835
• Study type: Observational [Patient Registry]
• Source: Relievant Medsystems, Inc.
• Status: Terminated
• Start date: July 31, 2020
• Completion date: December 1, 2022