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

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.

NCT Number	NCT06729255
Lead Sponsor	Oregon Health and Science University Collaborators: GuideStar Medical Devices
Conditions	Postdural Puncture Headache, Epidural Analgesia, Obstetric
Enrollment	100 participants
Start Date	2025-03-15
Primary Completion	2026-03-15 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-14