The Intracept Global Registry ( TIGR )

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

NCT06827262

Chronic Low-back Pain Vertebrogenic Pain Syndrome

RECRUITING

Study of the ReGelTec HYDRAFIL System

NCT04984629

Degenerative Disc Disease

COMPLETED NA

CLBP Single-Arm Long-Term Follow-up Study

NCT05207813

Chronic Low Back Pain

COMPLETED

SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

NCT04054401

Spinal Fusion Radiculopathy Lumbar Chronic Pain

RECRUITING NA

Comparison of the Order of Treatment in Lumbar Spinal Stenosis

NCT02103543

Lumbar Spinal Stenosis

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intracept Procedure

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zack McCormick

Assistant Professor and Director of Clinical Spine Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zachary McCormick, MD, FAAPMR

Role: PRINCIPAL_INVESTIGATOR

Spine and Pain Medicine, University of Utah School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIP 0014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions

NCT02609854 COMPLETED NA

PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.

NCT06715085 RECRUITING PHASE4

Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients With Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections

NCT05188820 COMPLETED NA

RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

NCT01716182 TERMINATED

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

NCT03997825 COMPLETED

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

NCT07254806 RECRUITING PHASE3

Spinal Cord Stimulation for Low Back Pain

NCT00205868 COMPLETED PHASE4

Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease

NCT06144970 NOT_YET_RECRUITING PHASE1

Transforaminal Epidural Steroid Injection With Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain Management

NCT02930057 UNKNOWN PHASE4

Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy

NCT01443819 TERMINATED PHASE3

Study of Cells From Spinal Cavity of Patients With Low Back Pain

NCT01089491 WITHDRAWN

An Implantable Spinal Cord Stimulation Pain Management System

NCT00205855 COMPLETED PHASE3

A Trial Comparing Three Orthobiologic Therapies on Atrophied Multifidus Muscles in Patients With Low Back Pain

NCT03618979 TERMINATED NA

Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis

NCT00786981 COMPLETED NA

Discogen for Low Back Pain

NCT06611397 RECRUITING NA

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome

NCT03614793 COMPLETED NA

Intradiscal Platelet Rich Plasma

NCT04544709 TERMINATED PHASE4

Combination Therapy With Atelocollagen in Epidural Nerve Block

NCT05014945 COMPLETED NA

SI Joint Fusion and Decortication Using the SImmetry System

NCT02560714 TERMINATED

Interbody Systems: Post Market Clinical Follow-up Study

NCT04911257 TERMINATED

Stronger Together Global Registry

NCT04364295 ENROLLING_BY_INVITATION

Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System

NCT01220505 COMPLETED

A Trial of Corticosteroids for Low Back Pain

NCT00290589 COMPLETED PHASE3

Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.

NCT02196883 WITHDRAWN NA

Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain

NCT02587637 COMPLETED NA

The Intracept Global Registry ( TIGR ) - Pilot Study