Postdural Puncture HeadachePhase 4NCT06729255
A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
A Phase 4 study testing EpiZact-assisted epidural placement in people with Postdural Puncture Headache and Epidural Analgesia, Obstetric, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Postdural Puncture Headache, Epidural Analgesia, Obstetric
- What is being tested?
- EpiZact-assisted epidural placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women requesting labor epidural analgesia
- Women pregnant with a single baby (not twins or triplets)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
Brandon M Togioka, MD, 503-494-4572, togioka@ohsu.edu
Sarah L Feller, 503-494-6233, fellersa@ohsu.edu
About this study
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
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:
- What the rate of wet tap with the EpiZact device?
- 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.
Read the 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.
- Being tested
- EpiZact-assisted epidural placement
- Keywords
- EpiZact, Wet Tap, unintentional dural puncture
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiZact-assisted epidural placementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EpiZact assisted epidural placement | Experimental | All patients enrolled in the study will receive an epidural to treat labor pain with the assistance of the EpiZact device. Receives: Device: EpiZact-assisted epidural placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with an Unintentional Dural Puncture
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.
Measured: 1 week
Secondary outcomes (1)
Proportion of Participants with Failed Labor Epidural Placement
Failed epidural placement will be defined as the inability to place a catheter in the epidural place or the need to replace the epidural within 2 hours of insertion. Decision to replace the epidural will be according to standard practice on labor and delivery at OHSU and will typically involve assessment of loss of cold to ice sensation in the lower thoracic and lumbar dermatomes, 50% decrease in labor contraction pain, and new lower extremity paresthesia.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Mar 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will perform a prospective cohort with retrospective loss-of-resistance comparator, proof of concept study involving patients undergoing epidural labor analgesia at OHSU University Hospital. This is an open-label (unblinded) study. The study will involve one arm: 1\) A prospectively enrolled convenience sample of patients that receive epidural labor analgesia with the assistance of the EpiZact device. Results will be matched with a sample of patients identified through retrospective chart review that have received standard of care epidural labor analgesia with the loss-of-resistance technique.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- GuideStar Medical Devices
- Responsible party
- Principal investigator, Brandon M Togioka, OHSU Knight Cancer Institute
- Investigators
- Brandon M Togioka, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729255
- Sponsor's protocol ID
- STUDY00027678
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is currently no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06729255
- Acronym / sponsor ID
- STUDY00027678
- Keywords
- EpiZact, Wet Tap, unintentional dural puncture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- GuideStar Medical Devices
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What the rate of wet tap with the EpiZact device?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will perform a prospective cohort with retrospective loss-of-resistance comparator, proof of concept study involving patients undergoing epidural labor analgesia at OHSU University Hospital. This is an open-label (unblinded) study. The study will involve one arm: 1) A prospectively enrolled convenience sample of patients that receive epidural labor analgesia with the assistance of the EpiZact device. Results will be matched with a sample of patients identified through retrospective chart review that have received standard of care epidural labor analgesia with the loss-of-resistance technique.
| Arm | Type | Receives |
|---|---|---|
| EpiZact assisted epidural placement | Experimental | Device: EpiZact-assisted epidural placementAll patients enrolled in the study will receive an epidural to treat labor pain with the assistance of the EpiZact device. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women requesting labor epidural analgesia
- Women pregnant with a single baby (not twins or triplets)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiZact-assisted epidural placementThe 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. | Device | EpiZact assisted epidural placement |
Primary outcome
Proportion of Participants with an Unintentional Dural Puncture
Time frame: 1 week
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.
1 secondary outcome
Proportion of Participants with Failed Labor Epidural Placement
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No. There is currently no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon M Togioka, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EpiZact-assisted epidural placement in people with Postdural Puncture Headache and Epidural Analgesia, Obstetric, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon M Togioka, MD (503-494-4572, togioka@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with an Unintentional Dural Puncture (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.