Recruiting

Compuflo CathCheck

Sponsor:

University of Minnesota

Code:

NCT06460155

Conditions

Epidural Placement

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

3 methods intervention

Study Details

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.

Conditions

Epidural Placement

Study ID

NCT06460155

Start date

Sep 30, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Experimental group

Interventions

3 methods intervention

Stu All participants will undergo all three methods being studied: epidurogram (gold standard), CompuFlo CathCheck, and physical exam in PACU following epidural placement.

Primary outcome measure

  • CompuFlo's Success [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Candace Nelson

nelso377@umn.edu

Kristine Kancans

kanca008@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Epidural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-07.