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

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record status
This record was last updated February 14, 2025 (before its estimated March 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Apr 30, 2025 to Mar 15, 2026v2 Show 7 more changesShow less
    • Start date: Jan 15, 2025 to Mar 15, 2025
    • Primary endpoint revised
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Secondary endpoint revised
    • Site contact updated
    • Study title expanded, about 10 words
    • Study description expanded, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06729255
Lead Sponsor Oregon Health and Science University
Collaborators: GuideStar Medical Devices
Conditions
(from sponsor)		 Postdural Puncture Headache, Epidural Analgesia, Obstetric
Related terms Post-Dural Puncture Headache
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov