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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age15-50
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant women requesting labor epidural analgesia

Women pregnant with a single baby (not twins or triplets)

Disqualifiers

Women requesting not to have a labor epidural

Height less than 150 cm

A bleeding disorder, nerve problem, or skin infection that contraindicates receiving an epidural

A women receiving a combined spinal epidural (CSE) or a dural puncture epidural (DPE)

Trial design

Treatments tested in this trial

  • EpiZact-assisted epidural placement

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Oregon Health and Science University

Lead sponsor

OHSU Knight Cancer Institute

Sponsor institution

GuideStar Medical Devices

Collaborator