| NCT ID | NCT06460155 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Minnesota |
| Condition | Epidural Placement |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2024-09-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.
Eligibility Criteria
Inclusion Criteria: * Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study. Exclusion Criteria: * All patients unable to receive or who refuse placement of epidural will be excluded * patients who are unable to consent * non-English speakers, pregnant individuals) * Individuals with known or who have an allergic reaction to bupivacaine
Contact & Investigator
Candace Nelson
✉ nelso377@umn.eduAaron Berg
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06460155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Epidural Placement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06460155 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06460155 currently recruiting?
Yes, NCT06460155 is actively recruiting participants. Contact the research team at nelso377@umn.edu for enrollment information.
Where is the NCT06460155 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06460155 clinical trial?
NCT06460155 is sponsored by University of Minnesota. The principal investigator is Aaron Berg at University of Minnesota. The trial plans to enroll 50 participants.