The Intracept Global Registry ( TIGR ) - Pilot Study

NCT04449835 | Terminated

• 1 other identifier: CIP 0014
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Oswestry Disability Index (ODI) improvement

  3, 12, 24, 36, 48 and 60 months post procedure

• Numeric Pain Score

  3, 12, 24, 36, 48 and 60 months post procedure

• Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)

  3, 12, 24, 36, 48 and 60 months post procedure

• PROMIS 29 Change

  3, 12, 24, 36, 48 and 60 months post procedure

• Injections utilization compared to baseline

  3, 12, 24, 36, 48 and 60 months post procedure

Interventions

Intracept Procedure PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Relievant Medsystems, Inc.: lead
• M Squared Associates, Inc.: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zachary McCormick, MD, FAAPMR

  Spine and Pain Medicine, University of Utah School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Director of Clinical Spine Research

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 29, 2020
• Study Start: July 31, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)