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NCT06729255 · ClinicalTrials.gov registry record · Phase 4
A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
A Phase 4 study, sponsored by Oregon Health and Science University.
- Not yet
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT06729255: Clinical Trial Phase 4 study, sponsored by Oregon Health and Science University.
NCT06729255 is a Phase 4 study that has not yet begun recruiting, run by Oregon Health and Science University. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06729255, a Phase 4 study, has not yet begun recruiting, sponsored by Oregon Health and Science University.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE EpiZact-assisted epidural placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-03-15 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What is known before NCT06729255 opens enrollment
NCT06729255 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which EpiZact-assisted epidural placement is the first listed.
NCT06729255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06729255 about?
NCT06729255 is a clinical study titled "A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device". 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 cerebrospin...
What is the current status of trial NCT06729255?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-03-15. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT06729255?
The interventions under investigation include: EpiZact-assisted epidural placement (DEVICE).
Who is sponsoring clinical trial NCT06729255?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06729255's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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