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

NCT06729255 | Not Yet Recruiting Phase 4 FDA Device

• 1 other identifier: STUDY00027678
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.What the rate of wet tap with the EpiZact device?
2. 2.What is the rate of failed epidural placement with the EpiZact device?

Conditions

Postdural Puncture Headache; Epidural Analgesia, Obstetric

Keywords

EpiZact; Wet Tap; unintentional dural puncture

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with an Unintentional Dural Puncture

  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.

  1 week

Secondary Outcomes (1)

• Proportion of Participants with Failed Labor Epidural Placement

  2 hours

Study Arms (1)

EpiZact assisted epidural placement

EXPERIMENTAL

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

Device: EpiZact-assisted epidural placement

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.

EpiZact assisted epidural placement

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• GuideStar Medical Devices: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon M Togioka, MD

CONTACT

503-494-4572; togioka@ohsu.edu

Sarah L Feller

CONTACT

503-494-6233; fellersa@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Clinical Research, Anesthesiology and Perioperative Medicine

Model Details: The investigators will perform a prospective cohort with retrospective loss-of-resistance comparator, proof of concept study involving patients undergoing epidural labor analgesia at OHSU University Hospital. This is an open-label (unblinded) study. The study will involve one arm: 1\) A prospectively enrolled convenience sample of patients that receive epidural labor analgesia with the assistance of the EpiZact device. Results will be matched with a sample of patients identified through retrospective chart review that have received standard of care epidural labor analgesia with the loss-of-resistance technique.

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: March 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)