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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06729255
The ClinicalTrials.gov registry entry for NCT06729255 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EpiZact-assisted epidural placement is the first listed.
NCT06729255 reports 0 study locations.
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.
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