Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study

NCT07720908 | Recruiting DMC FDA Device

• 1 other identifier: 2023H0188
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the use of the CompuFlo® CathCheck™ System to assess labor epidural catheter function before reactivation for postpartum tubal ligation. The study aims to determine whether this technology can accurately identify functional versus dysfunctional epidural catheters compared with standard clinical assessment methods. Improving catheter assessment may reduce failed epidural reactivation, the need for additional anesthesia techniques, and improve patient safety.

Conditions

Anesthesia, Epidural

Keywords

Labor epidural catheter; Epidural catheter dysfunction; CompuFlo CathCheck System; Tubal ligation in parturients

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Labor Epidural Catheter Reactivation

  The percentage of participants with successful use of the existing labor epidural catheter for postpartum tubal ligation without evidence of catheter failure or the need for alternative anesthesia techniques (e.g., conversion to general anesthesia or spinal anesthesia).

  Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)

Secondary Outcomes (9)

• Sensitivity of the CompuFlo® CathCheck™ System

  Pre-procedural (prior to epidural reactivation)

• Specificity of the CompuFlo® CathCheck™ System

  Pre-procedural (prior to epidural reactivation)

• Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System

  Pre-procedural (prior to epidural reactivation)

• Number of Dermatomal Sensory Block Levels After Epidural Test Dose

  Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)

• Duration of Labor Epidural Catheter Unused Time

  Periprocedural (from delivery until epidural reactivation)

Study Arms (1)

Labor Epidural Reactivation Cohort

EXPERIMENTAL

Postpartum women undergoing elective tubal ligation after vaginal delivery with an indwelling labor epidural catheter. Participants will undergo standard epidural catheter assessment and reactivation, including evaluation with the CompuFlo® CathCheck™ System to determine catheter functionality and predict successful epidural anesthesia for the tubal ligation procedure.

Device: CompuFlo® CathCheck™ System Assessment

Interventions

CompuFlo® CathCheck™ System Assessment DEVICE

Evaluation of labor epidural catheter functionality using the CompuFlo® CathCheck™ System following standard epidural test-dose administration and prior to epidural reactivation for postpartum tubal ligation.

Labor Epidural Reactivation Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be biologically female postpartum women aged 18 years or older who have undergone vaginal delivery, have an indwelling labor epidural catheter in place, and have elected to undergo postpartum tubal ligation. Because postpartum tubal ligation is a procedure performed in women following childbirth, only female participants are eligible for enrollment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Postpartum women electing to undergo tubal ligation with an indwelling labor epidural catheter
• Ability to provide informed consent in English
• Vaginal delivery

You may not qualify if:

• Parturients not receiving labor epidural analgesia or receiving an alternative anesthetic technique during labor and delivery
• Epidural catheter located \>2 cm from the documented insertion depth at initial placement
• Planned elective cesarean delivery
• Chronic pain conditions (e.g., chronic low back pain, sickle cell disease)
• Chronic opioid use disorder
• Chronic gabapentin use
• Uncontrolled mood disorders that, in the investigator's judgment, may interfere with study participation or interpretation of study outcomes
• Prisoners or incarcerated individuals

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Central Study Contacts

Ling-Qun Hu, MD

CONTACT

6142933559; LingQun.Hu@osumc.edu

Alberto Uribe Vega

CONTACT

6142933559; alberto.uribe@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. Participants, anesthesia care providers, investigators, and outcome assessors are not masked to the CompuFlo® CathCheck™ System assessment. The device evaluation is performed as part of the study procedures, and the results are recorded prospectively. The primary outcome is based on predefined objective clinical criteria for successful labor epidural catheter reactivation, including sensory block assessment and the need for conversion to another anesthetic technique or additional anesthetic interventions.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: All enrolled participants will undergo the same study procedures. Following vaginal delivery and prior to postpartum tubal ligation, participants with an indwelling labor epidural catheter will receive the standard clinical epidural test dose and assessment, followed by evaluation with the CompuFlo® CathCheck™ System to detect epidural pulsatile waveform pressure. The diagnostic performance of the CompuFlo® system will be compared with the clinical reference standard for successful epidural catheter reactivation.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start: December 19, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)