Accuracy of the Accuro 3S

NCT07458087 | Not Yet Recruiting FDA Device

• 1 other identifier: 2000036235
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural). The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.

Conditions

Neuraxial Technique

Keywords

regional anesthesia/analgesia; spinal anesthesia; epidural

Outcome Measures

Primary Outcomes (3)

• Mean number of needle attempts

  Defined as the number of times the needle is inserted into patients back

  At time of procedure, 1 day

• Mean number of needle redirections

  Defined as number of needle movements in a cephalad, caudal or lateral position.

  At time of procedure, 1 day

• Accuracy of device

  The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm).

  At time of procedure, 1 day

Secondary Outcomes (1)

• Patient satisfaction

  20 minutes post procedure

Study Arms (1)

Standard of Care and neuraxial guidance

EXPERIMENTAL

Spinal or Epidural will be performed utilizing neuraxial guidance and standard of care techniques for placement. The spinal or epidural technique will not deviate from the standard of care. The device will only add the use of the disposable sterile drape and the use of the image will guide change of needle trajectory (without the need for contrast or radiation exposure) but not changing the technique.

Device: ACCURO 3S

Interventions

ACCURO 3S DEVICE

Provides anatomical guidance during the placement of needles or catheters using real-time visualization.

Standard of Care and neuraxial guidance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The anesthetic plan for the patient includes a neuraxial anesthetic (spinal or epidural) as the main anesthetic for labor, surgery (e.g. orthopedic surgery, cesarean delivery) or for postoperative pain management (e.g, major abdominal surgery). \*Given our labor and delivery volume (\~300 epidurals/month) investigators think that they will only recruitc obstetric patients. In case of difficulty recruiting, then investigators will seek out a different patient population.
• No history of allergic reactions to adhesives used in standard epidural placements as per chart review or self-reported.
• Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
• The patient is English speaking.
• For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor. \*Clarification - Patients scheduled for elective cesarean delivery will be approached for spinal anesthesia. Given that spinal anesthesia carries a smaller risk for post-dural puncture headache and other morbidities, investigators will recruit and perform 10 spinals on this patient population. Once comfortable with the technology, then will move to recruiting and performing epidurals. If during the spinal anesthesia trial the device does not provide accurate and clear needle visualization, the study will be culminated.

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 100, 000, 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 18.5 kg/m2.

Sponsors & Collaborators

• Yale University: lead
• Rivanna Medical, Inc.: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Gonzalez-Fiol, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Gonzalez-Fiol, MD

CONTACT

203-785-2802; antonio.gonzalez-fiol@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Anticipated 10 spinal and 40 epidural procedures.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)