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Procedure

Ultrasound Device for Labor Pain and C-sections

N/A
Waitlist Available
Led By Clemens Ortner, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years or older
Patient skin is intact in the area of placement of the epidural or spinal anesthesia
Must not have
Unable to assume sitting position
Presence of orthopedic implants in the spine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to develop a device that can improve the accuracy and safety of neuraxial anesthesia procedures by providing real-time needle visualization and guidance. The device, called Accuro 3S, will

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As this trial involves a non-invasive imaging device, there are minimal expected side effects directly from the device itself. However, standard risks associated with neuraxial anesthesia such as soreness or infection at the injection site may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My skin is healthy where the epidural or spinal anesthesia will be placed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot sit up by myself.
Select...
I have orthopedic implants in my spine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of difficult block placement
Secondary study objectives
Incidence of failed block
Incidence of post-dural puncture headache

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intrathecal neuraxial procedureExperimental Treatment1 Intervention
Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,485 Previous Clinical Trials
17,517,233 Total Patients Enrolled
5 Trials studying Labor Pain
320 Patients Enrolled for Labor Pain
Rivanna Medical, Inc.UNKNOWN
Clemens Ortner, MDPrincipal InvestigatorStanford University
~18 spots leftby Mar 2025
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