A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 15, 2025

Primary Completion Date

March 15, 2026

Study Completion Date

December 31, 2026

Conditions
Postdural Puncture HeadacheEpidural Analgesia, Obstetric
Interventions
DEVICE

EpiZact-assisted epidural placement

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.

Trial Locations (1)

97239

Oregon Health and Science University, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GuideStar Medical Devices

UNKNOWN

lead

Oregon Health and Science University

OTHER