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Procedure

Intrathecal neuraxial procedure for Labor Pain

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of difficult block placement

Secondary outcome measures

Incidence of failed block

Incidence of post-dural puncture headache

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,396 Previous Clinical Trials

17,341,455 Total Patients Enrolled

5 Trials studying Labor Pain

300 Patients Enrolled for Labor Pain

Rivanna Medical, Inc.UNKNOWN

Clemens Ortner, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are above the age of 60 eligible to participate in this clinical trial?

"Participants being sought for this research study need to be above 18 years old but below 65 years of age."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"Individuals experiencing labor pain and aged between 18 to 65 are eligible for participation in this trial, which aims to enroll approximately 100 participants."

Answered by AI

Are there any ongoing efforts to enroll participants in this clinical study at the moment?

"Information from clinicaltrials.gov reveals that this research project, initially shared on February 1st 2024 and last revised on February 20th 2024, is not actively recruiting participants. Despite this trial being inactive in recruitment status, it's noteworthy that there are currently 30 other trials seeking eligible candidates for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuraxial Ultrasound Device Study

Clemens Ortner 2024. "Neuraxial Ultrasound Device Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06281249.