Ultrasound Device for Labor Pain and C-sections

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Anticoagulants

Disqualifiers: Bleeding disorders, Neurological dysfunction, Spinal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clemens Ortner, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals experiencing labor pain or preparing for a C-section who require neuraxial anesthesia. The study seeks participants to test an ultrasound device designed to improve the accuracy of needle placement during epidural and spinal procedures.

Inclusion Criteria

I am eligible and have agreed to undergo spinal or epidural anesthesia.

My skin is healthy where the epidural or spinal anesthesia will be placed.

Exclusion Criteria

Skin dyscrasias or allergies to the ultrasound procedure

Body Mass Index (BMI) less than 20 kg/m2

Known allergies to ultrasound gel

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive neuraxial anesthesia with the investigational device Accuro 3S, including ultrasound-guided needle placement and image recording

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the neuraxial procedure, including incidence of post-dural puncture headache and failed block

7 days

1 follow-up call

Treatment Details

Interventions

• Ultrasound Placement Device

Trial Overview The Accuro 3S, an experimental ultrasound device, is being tested for its ability to guide clinicians in real-time during needle insertion for neuraxial anesthesia. It aims to enhance safety by providing precise anatomical guidance and improving needle visualization.

Participant Groups

Group I: Intrathecal neuraxial procedure Experimental Treatment 1 Intervention

Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Rivanna Medical, Inc.

Collaborator

Trials

1

Recruited

100+