Neuraxial Ultrasound Device Study

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06281249
Status
Not Yet Recruiting

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Conditions

  • Cesarean Delivery Regional Anesthesia Induction
  • Labor Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound placement device — DEVICE
    Device to assist in placement of epidural procedure

Study Details

The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.

Key Dates

Start date
Dec 15, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intrathecal neuraxial procedure
    Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.

Primary Outcome Measure

Incidence of difficult block placement [ Time Frame: 15 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford University· Stanford, CA

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