Clinical trial NCT04449835: The Intracept Global Registry ( TIGR ) - Pilot Study
Official title: The Intracept Global Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain
Lead sponsor: Relievant Medsystems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: M Squared Associates, Inc.
First posted: 2020-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that have the Intracept procedure and whose treating physician is referring to the registry

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Oswestry Disability Index (ODI) Reduction
timeFrame: 3 months post procedure
Secondary outcomes:
measure: Oswestry Disability Index (ODI) improvement
timeFrame: 3, 12, 24, 36, 48 and 60 months post procedure
measure: Numeric Pain Score
timeFrame: 3, 12, 24, 36, 48 and 60 months post procedure
measure: Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)
timeFrame: 3, 12, 24, 36, 48 and 60 months post procedure
measure: PROMIS 29 Change
timeFrame: 3, 12, 24, 36, 48 and 60 months post procedure
measure: Injections utilization compared to baseline
timeFrame: 3, 12, 24, 36, 48 and 60 months post procedure
measure: Post ablation pain interventions/surgeries
timeFrame: 3, 12, 24, 36, 48 and 60 months post procedure
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Spine and Pain Medicine, University of Utah School of Medicine
name: Zachary McCormick, MD, FAAPMR
role: PRINCIPAL_INVESTIGATOR
References: