MedTrace Logo

A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device

NCT06729255 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-14

No results posted yet for this study

Summary

The purpose of the study is to learn more about a new device, the EpiZact Epidural Device, that may be helpful for reducing the likelihood of wet tap when a labor epidural is placed. When epidurals are placed correctly the needle stops just in front of the space in the body that contains cerebrospinal fluid. When the epidural is advanced a short distance further, leakage of cerebrospinal fluid can occur. This is known as a wet tap. A wet tap can result in a severe headache and at times other complications. The goal of this clinical trial is to learn if the use of the EpiZact device prevents wet taps in pregnant women receiving epidurals for relief of labor pain. The main questions this study aims to answer are:

1. What the rate of wet tap with the EpiZact device?
2. What is the rate of failed epidural placement with the EpiZact device?

All patients in the study will receive an epidural with the EpiZact device. The investigators will compare the results with patients not in the study that receive an epidural without the EpiZact device.

Conditions

  • Postdural Puncture Headache
  • Epidural Analgesia, Obstetric

Interventions

DEVICE

EpiZact-assisted epidural placement

The standard epidural kit used with the EpiZact device to place a midline epidural using the landmark technique between the L2 and L5 vertebral bodies. The patient's back will be sterilized with a 2% chlorhexidine/70% isopropyl alcohol applicator. The epidural will be placed with a 17-gauge 3.5-inch Tuohy needle. Once the Tuohy needle is appreciated to be engaged in ligament the EpiZact device will be filled with sterile and attached to the Tuohy via a Luer connector. The green button on the EpiZact device will then be pressed to prime the device. The EpiZact device and Tuohy needle will be advanced as a unit in continuous fashion or with intermittent advancement. Upon sensing a loss of resistance, the EpiZact device will provide a visual and tactile signal, halting needle advancement and signaling that the epidural catheter should be threaded through the Tuohy needle.

Sponsors & Collaborators

  • GuideStar Medical Devices

    collaborator UNKNOWN

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Brandon M Togioka, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2026-03-15
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729255 on ClinicalTrials.gov