CompuFlo CathCheck

NCT06460155 | Recruiting Phase 4 FDA Device

• 1 other identifier: ANES-2024-32648
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Epidural

Outcome Measures

Primary Outcomes (1)

• CompuFlo's Success

  The measure is a binary outcome: the epidural catheter is in the epidural space or not. Each modality assessed will either conclude positive (in the correct space) no negative (notnint he correct space) There is no "value". The tools used for the assessment is actually what is being studied, compuflo, meniscus test, physical exam and epidurogram.

  baseline

Study Arms (1)

Experimental group

EXPERIMENTAL

Device: 3 methods intervention

Interventions

3 methods intervention DEVICE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Study Officials

• Aaron Berg

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Nelson

CONTACT

nelso377@umn.edu

Kristine Kancans

CONTACT

kanca008@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective diagnostic accuracy study. All participants will undergo all three methods being studied: epidurogram (gold standard), CompuFlo CathCheck, and physical exam in PACU following epidural placement.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 14, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)