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

Conditions

• Epidural Analgesia, Obstetric
• Postdural Puncture Headache

Eligibility Criteria

Sex

FEMALE

Age

15 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• EpiZact-assisted epidural placement — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Mar 15, 2025

Status verified

Feb 2025

Primary completion

Mar 15, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: EpiZact assisted epidural placement
  All patients enrolled in the study will receive an epidural to treat labor pain with the assistance of the EpiZact device.

Primary Outcome Measure

Proportion of Participants with an Unintentional Dural Puncture [ Time Frame: 1 week ]

Central Contacts

• Brandon M Togioka, MD
  503-494-4572
  [email protected]
• Sarah L Feller
  503-494-6233
  [email protected]

Locations (1)

Find similar trials in Portland, OR

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