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Evaluation of the EpiZact Device

Phase 4
Waitlist Available
Led By Brandon M Togioka, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Pregnant women requesting labor epidural analgesia
* Women pregnant with a single baby (not twins or triplets)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours

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. We will compare the results with patients not in the study that receive an epidural without the EpiZact device.

Eligible Conditions
  • Spinal headache
  • Epidural Analgesia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Unintentional dural puncture
Secondary study objectives
Failed labor epidural placement

Trial Design

1Treatment groups
Experimental Treatment
Group I: EpiZact assisted epidural placementExperimental Treatment1 Intervention
All patients enrolled in the study will receive an epidural to treat labor pain with the assistance of the EpiZact device.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,007 Previous Clinical Trials
7,414,073 Total Patients Enrolled
GuideStar Medical DevicesUNKNOWN
Brandon M Togioka, MDPrincipal InvestigatorOregon Health and Science University
8 Previous Clinical Trials
1,052 Total Patients Enrolled
~67 spots leftby Apr 2025