Neuraxial Ultrasound Device Study

Starting soon · Not applicable

Conditions studied: Labor Pain, Cesarean Delivery Regional Anesthesia Induction

In brief

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 facts

Study ID

NCT06281249

Run by

Stanford University

People needed

100

Starts

2026-12-15

Expected to finish

2027-12-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older
• The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.
• Patient skin is intact in the area of placement of the epidural or spinal anesthesia.

You may not qualify if…

• Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/μL, or evidence of infection at potential epidural site.
• Presence of orthopedic implants in the spine.
• Skin dyscrasias or allergies to the ultrasound procedure.
• Unable to assume sitting position.
• Body Mass Index (BMI) less than 20 kg/m2.
• Known allergies to ultrasound gel.
• Known history of allergic reactions to adhesives used in standard epidural placement

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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