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Clinical Trial Summary

This is an independent prospective, noninterventional, observational post-market data collection of the patient-reported effectiveness, ongoing safety and satisfaction outcomes for patients treated with the Intracept Procedure at a single study site.


Clinical Trial Description

The Investigator Sponsor will initially approach patients planning to undergo the Intracept Procedure to discuss their interest in learning more about the study. With patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather Verbal Informed Consent. Study data will be collected by the third-party research organization via 4 telephone study visits under the direction of the Sponsor Investigator. The third-party research organization will enter the study data directly into a study database and issue the subject stipend at the completion of each study visit. Data will be analyzed by a third-party statistician under the direction of the Sponsor Investigator for this single-site study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05660512
Study type Observational
Source University of Utah
Contact
Status Suspended
Phase
Start date July 27, 2020
Completion date July 2026

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