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EpiZact Device for Reducing Postdural Puncture Headache

This study is testing a new device called EpiZact that aims to make epidural placement safer for pregnant women in labor. When an epidural is placed, there's a small risk of a "wet tap," which is when the needle goes a little too far and causes a leak of spinal fluid. This can lead to a severe headache (Postdural Puncture Headache). The EpiZact device has technology designed to automatically stop the needle at the right spot, potentially reducing the chance of a wet tap. Researchers want to see how often wet taps occur when the EpiZact device is used. You may be able to join if you are a pregnant woman between 15 and 50 years old, expecting one baby, and requesting an epidural for labor pain.

Study design
This is an interventional study planning to enroll 100 participants. All participants will receive an epidural with the EpiZact device, and results will be compared to patients receiving standard epidurals.
What's involved
If you join, your medical records may be reviewed. You will receive an epidural with the EpiZact device, answer a few questions about how it's working, and receive a follow-up call one week later.
Compensation
Not stated in the trial record.
Follow-up
You will be contacted one week after receiving the epidural to check for any complications.

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NCT06729255

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

Not Yet Recruiting
PHASE4Ages 15–50InterventionalPrevention
Oregon Health and Science University
~100 participants
Updated 2025-02-14 on ClinicalTrials.gov
What's tested:EpiZact-assisted epidural placement

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with an Unintentional Dural Puncture
Measured over 1 week

Conditions

Postdural Puncture Headache
Epidural Analgesia, Obstetric

Explore related trials

Labor

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

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

Who to contact

Brandon M Togioka, MD
[email protected]
503-494-4572
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnant women requesting labor epidural analgesia
Women pregnant with a single baby (not twins or triplets)

Exclusion

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)
A history of spine surgery
Allergy to local anesthetics (numbing medicine) or skin cleaning solutions
Decisionally impaired individuals

What this trial measures

  • Proportion of Participants with an Unintentional Dural Puncture1 week

    Unintentional dural puncture will be a composite outcome diagnosed by any of the following: (1) free flow of cerebrospinal fluid from the Tuohy needle at any time during the epidural technique, (2) requirement of blood patch within one week of neuraxial procedure, or (3) postural headache that worsens with upright posture and improves with supine position diagnosed within one week of neuraxial placement.