The Intracept Global Registry ( TIGR ) - Pilot Study

The Intracept Global Registry

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Intracept Procedure

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients that have the Intracept procedure and whose treating physician is referring to the registry

Description

Inclusion Criteria:

All patients scheduled for the Intracept procedure and whose treating physician is referring to the registry

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) Reduction	Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.	3 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) improvement	Mean improvement in ODI scores from baseline (scale 0 to 100)	3, 12, 24, 36, 48 and 60 months post procedure
Numeric Pain Score	Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)	3, 12, 24, 36, 48 and 60 months post procedure
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)	Percent of responders meeting both thresholds	3, 12, 24, 36, 48 and 60 months post procedure
PROMIS 29 Change	Mean change in PROMIS-29 from baseline	3, 12, 24, 36, 48 and 60 months post procedure
Injections utilization compared to baseline	Numbers of injections post procedure compared to baseline	3, 12, 24, 36, 48 and 60 months post procedure
Post ablation pain interventions/surgeries	Numbers of pain interventions/surgeries post procedure compared to baseline	3, 12, 24, 36, 48 and 60 months post procedure

Collaborators and Investigators

• Sponsor: Relievant Medsystems, Inc.
• Collaborators: M Squared Associates,Inc.
• Investigators: Principal Investigator: Zachary McCormick, MD, FAAPMR, Spine and Pain Medicine, University of Utah School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIP 0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No