A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
Public ClinicalTrials.gov record NCT06729255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single Academic Center, Prospective Cohort With Retrospective Loss-of-resistance Comparator, Proof of Concept Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device for Parturients Undergoing Epidural Labor Analgesia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06729255
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 100 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 15 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 14, 2025
- Primary completion
- Mar 14, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Feb 13, 2025
2025 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06729255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 13, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06729255 live on ClinicalTrials.gov.