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

NCT ID: NCT06729255

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2026-12-31

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. 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.

Detailed Description

The purpose of the study is to learn if use of the EpiZact device decreases the number of wet taps that occur when epidurals are placed. The EpiZact device has a technology that automatically stops the epidural needle when it enters the epidural space. In theory, this should decrease the likelihood of a wet tap. The standard epidural to treat labor pain does not have this capability. The study device may cause fewer wet taps than the standard epidural. All study participants will receive an epidural to treat labor pain with the EpiZact device. Results will be compared with patients receiving epidurals around the same time without the EpiZact device.

If a participant's screening questions show that they can take part in the study, and the participant chooses to be a part of the study, medical records from OHSU or other facilities may be reviewed. Information reviewed may include treatment history, medications, surgeries, allergies, scans, and lab results. The participant will then receive an epidural with the EpiZact device. After the epidural is placed, the participant will be asked a few questions to determine how well the epidural is working and if a complication occurred. The questions are expected to take less than 5 minutes to answer. Participants will also be called 1 week after receiving an epidural to determine if a complication occurred. This call is expected to last less than 5 minutes.

Conditions

Postdural Puncture Headache; Epidural Analgesia, Obstetric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EpiZact-assisted epidural placement

Intervention Type: 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.

Interventions

EpiZact-assisted epidural placement

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GuideStar Medical Devices

UNKNOWN

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Brandon M Togioka

Vice Chair of Clinical Research, Anesthesiology and Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandon M Togioka, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Central Contacts

Brandon M Togioka, MD

Role: CONTACT

togioka@ohsu.edu

503-494-4572

Sarah L Feller

Role: CONTACT

fellersa@ohsu.edu

503-494-6233

Facility Contacts

Brandon M Togioka, MD

Role: primary

togioka@ohsu.edu

503-494-4572

Sarah L Feller

Role: backup

fellersa@ohsu.edu

503-494-6233

Other Identifiers

STUDY00027678

Identifier Type: -

Identifier Source: org_study_id