CompuFlo CathCheck

NCT ID: NCT06460155

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epidural Placement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

3 methods intervention

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Berg

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Candace Nelson

Role: CONTACT

Kristine Kancans

Role: CONTACT

Facility Contacts

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Candace Nelson

Role: primary

Other Identifiers

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ANES-2024-32648

Identifier Type: -

Identifier Source: org_study_id

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