The Intracept Global Registry

  • STATUS
    Recruiting
  • End date
    Jun 15, 2029
  • participants needed
    5000
  • sponsor
    Relievant Medsystems, Inc.
Updated on 15 October 2021
back pain
low back pain

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 registry will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.

Details
Condition Lower Back Pain, Low Back Pain, lumbago, Chronic Back Pain, Back Pain
Treatment Intracept Procedure
Clinical Study IdentifierNCT04449835
SponsorRelievant Medsystems, Inc.
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

No exclusion criteria
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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