Accuro 3S for Spinal Anesthesia

AG
Overseen ByAntonio Gonzalez-Fiol, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Accuro 3S, a new device that provides real-time guidance for administering spinal or epidural anesthesia. The researchers seek to determine if this device can match the accuracy and safety of X-rays without the associated radiation. It may suit patients requiring spinal or epidural anesthesia for childbirth or surgery, provided they have no skin issues or allergies related to the procedure. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance anesthesia safety and accuracy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using anti-coagulants (blood thinners), you may not be eligible to participate.

What prior data suggests that the Accuro 3S device is safe for neuraxial guidance?

Previous studies have shown positive safety results for the Accuro 3S device. Research indicates that the device is effective and safe for assisting doctors with spinal and epidural procedures. It employs advanced ultrasound technology to help doctors accurately locate the spot for needle placement, reducing reliance on other imaging methods like X-rays.

The device has received FDA clearance, confirming it meets specific safety standards for medical use. Reports suggest it provides accurate guidance without adding extra risks to patients. Consequently, the Accuro 3S is considered safe and well-tolerated by patients undergoing spinal anesthesia procedures.12345

Why are researchers excited about this trial?

Most treatments for spinal anesthesia rely on standard techniques that can sometimes be challenging due to the need for precise needle placement. However, the Accuro 3S is unique because it enhances these standard methods with neuraxial guidance. This device uses real-time imaging to help guide the needle's trajectory without relying on contrast or exposing patients to radiation. Researchers are excited because this method aims to improve accuracy and safety, potentially making spinal and epidural procedures more effective and less prone to complications.

What evidence suggests that the Accuro 3S is effective for neuraxial guidance?

Studies have shown that the Accuro 3S device significantly improves the chances of successfully inserting spinal and epidural needles on the first try, achieving a 72.5% success rate compared to 40% with traditional methods. This increases the likelihood of correct needle placement on the first attempt. The device also reduces the risk of complications such as tingling or numbness during the procedure. In some cases, particularly with patients who are more challenging to treat, the Accuro device increased success rates by up to 26%. The Accuro 3S uses ultrasound technology to guide doctors, eliminating the need for X-rays and making the process safer and more convenient. Participants in this trial will receive spinal or epidural procedures using the Accuro 3S for neuraxial guidance alongside standard care techniques.12356

Who Is on the Research Team?

AG

Antonio Gonzalez-Fiol, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for English-speaking patients needing spinal or epidural anesthesia, such as those having a C-section or surgery. Participants must have healthy skin at the procedure site and no allergies to adhesives or ultrasound gel. People with spine implants, certain skin conditions, very low BMI, or who can't sit up are excluded.

Inclusion Criteria

No history of allergic reactions to adhesives used in standard epidural placements
The patient is English speaking
For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor
See 2 more

Exclusion Criteria

Presence of orthopedic implants in the spine
Skin dyscrasias or allergies to the ultrasound procedure
I cannot sit up on my own.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Spinal or epidural procedure performed using the Accuro 3S device for live neuraxial guidance

1 day
1 visit (in-person)

Immediate Follow-up

Patient satisfaction assessed 20 minutes post-procedure

20 minutes

Follow-up

Participants are monitored for any adverse effects and overall procedure effectiveness

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ACCURO 3S

Trial Overview

The study tests the Accuro 3S device, which uses live imaging to help doctors accurately place needles for spinal or epidural anesthesia. The goal is to see if this new tool works as well as current methods in guiding these procedures.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Standard of Care and neuraxial guidanceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Rivanna Medical, Inc.

Industry Sponsor

Rivanna Medical, LLC

Collaborator

Trials
1
Recruited
130+

Citations

A systematic review and meta-analysis of randomised ...

Accuro can potentially improve success rates and reduce skin passes in neuraxial anaesthesia. Further trials with larger samples are needed, ...

RIVANNA's Accuro Shows Statistically Significant Efficacy ...

Compared to traditional palpation for bony landmarks, the Accuro-guided technique provided significant first-insertion success rates (72.5 ...

3.

rivannamedical.com

rivannamedical.com/accuro-qa/

Accuro's Statistical Significance, Ease of Use, and Accuracy

Specifically, Accuro provides significant first-insertion success rates: 72.5 percent vs. 40.0 percent and reductions in paresthesia: 7.5 ...

Does preprocedural ultrasound prior to lumbar neuraxial ...

Preprocedural ultrasound (PPU) reduces the risk of technical failure in non‐obese patients and when technical difficulty is predicted.

Accuracy of the Accuro 3S - ClinicalTrials.Veeva

The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a ...

Implementation of a Pre-procedural Ultrasound-based ... - DTIC

Rivanna Medical's Accuro device is a low-profile, hand-held device that uses three- dimensional spinal ultrasound navigational software to give anesthesia ...