The Intracept Global Registry ( TIGR ) - Pilot Study

Low Back Pain Clinical Trial

Official title:

The Intracept Global Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04449835
• Other study ID #: CIP 0014
• Status: Terminated
• Start date: July 31, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Relievant Medsystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Procedure:
• Intracept Procedure
radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Relievant Medsystems, Inc.	M Squared Associates,Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	PROMIS 29 Change	Mean change in PROMIS-29 from baseline	3, 12, 24, 36, 48 and 60 months post procedure
Secondary	Injections utilization compared to baseline	Numbers of injections post procedure compared to baseline	3, 12, 24, 36, 48 and 60 months post procedure
Secondary	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