25000 Participants NeededMy employer runs this trial

Accuro XV Ultrasound for Bone and Soft-Tissue Injuries

Recruiting at 9 trial locations
DL
JK
Overseen ByJoseph Kilroy, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Rivanna Medical, Inc.
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 tests a new ultrasound device called the Accuro XV, designed to improve imaging of bone and soft-tissue injuries in areas such as the wrist, forearm, ankle, or lower leg. The trial aims to determine if this ultrasound provides clear images and remains comfortable and safe for patients. Participants who have already undergone a standard X-ray for their injury will receive an additional ultrasound scan. This trial is open to individuals who recently had an X-ray for a suspected injury in the specified areas and are English or Spanish speakers. The results will help refine the device for future use but will not influence any current medical treatment decisions. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative imaging technology that could enhance future diagnostic procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on imaging and does not involve medication.

What prior data suggests that the Accuro XV Ultrasound Imaging System is safe for use in imaging bone and soft-tissue injuries?

Research has shown that the FDA has approved the Accuro XV ultrasound system, confirming its safety for use. This ultrasound allows doctors to view bones and soft tissues clearly without radiation, unlike X-rays or CT scans, which may raise safety concerns.

Ultrasound imaging is generally considered safe and is widely used due to its minimal risk to patients. Studies have not reported any serious side effects with the Accuro XV. The device provides clear images while prioritizing patient safety.12345

Why are researchers excited about this trial?

Researchers are excited about the Accuro XV Ultrasound Imaging System because it offers a new way to visualize bone and soft-tissue injuries. Unlike standard imaging techniques like X-rays or MRIs, which can be costly and time-consuming, the Accuro XV provides real-time imaging right at the bedside. This system has the potential to enhance image quality and safety while also supporting the development of advanced diagnostic algorithms. By allowing healthcare professionals to see injuries more clearly and quickly, it could revolutionize how we assess and manage these injuries.

What evidence suggests that the Accuro XV ultrasound is effective for imaging bone and soft-tissue injuries?

Research has shown that the Accuro XV Ultrasound Imaging System holds promise for examining bone and soft-tissue injuries. In a study with 205 patients, over 90% of the scans were clear enough for doctors to use for diagnosis, demonstrating the device's effectiveness. In this trial, participants with distal extremity injuries will receive additional imaging with the Accuro XV system after standard-of-care imaging. This ultrasound tool uses advanced technology to enhance the visibility of injuries like fractures. Although still under evaluation, these early results suggest it could be a reliable option for diagnosing bone and soft-tissue problems.13567

Are You a Good Fit for This Trial?

This trial is for people with suspected injuries to their wrist, forearm, ankle, or lower leg (like fractures or sprains) who have already had standard imaging done at a clinic or hospital. Participants must be able to undergo an extra ultrasound scan using the Accuro XV device.

Inclusion Criteria

English and/or Spanish speaking
The patient is scheduled to receive an X-ray that includes a view of the ankle, lower leg, wrist, and/or forearm or any patient that received an X-ray accessible by the study team for the studied anatomy in the past 48 hours
I am at least 5 years old.
See 1 more

Exclusion Criteria

Patients for whom the site investigator feels that study participation could prohibit or impair ongoing medical care
I have a severe open wound or broken bone with my limb bent at an abnormal angle.
Known allergy to ultrasound couplants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo additional imaging with the Accuro XV ultrasound system after standard-of-care imaging

1 day
1 visit (in-person)

Retrospective Image Quality Assessment

Retrospective assessment of acquired Accuro XV images for artifacts and other visual imperfections to evaluate image quality and suitability for subsequent analysis and algorithm development

Up to 48 months

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Accuro XV Ultrasound Imaging System

Trial Overview

The study is testing the Accuro XV Ultrasound Imaging System—a new bedside ultrasound tool designed to better detect bone and soft tissue injuries—by comparing its images and patient comfort levels with those from standard imaging methods.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Accuro XV ImagingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rivanna Medical, Inc.

Lead Sponsor

Citations

RIVANNA receives FDA 510(k) clearance for Accuro XV ...

enrolled 205 patients and found that more than 90% of scans in both operator groups were rated adequate for diagnostic interpretation.

Rivanna's Accuro XV Advances Ultrasound in Fracture Triage

Active closure significantly lowers the risk of hematomas and bleeding compared to manual pressure methods. operational efficiency.

Imaging Techniques For Diagnosing Musculoskeletal Injuries

Unlock the secrets of your body! Explore cutting-edge imaging to accurately diagnose musculoskeletal injuries. Read our article to learn more...

RIVANNA Initiates Study of Accuro XV Musculoskeletal ...

The study will acquire fracture images to evaluate device safety, ability to integrate in a workflow and ability to render automated ...

[PDF] Update in Musculoskeletal Ultrasound Research

This review provides an overview of classical machine learning techniques and modern deep learning approaches for musculoskeletal US, detect joint damage, to ...

Accuro-XV-Ultrasound-Imaging-System-for-BoneEnhance ...

MR blockade preserves skeletal integrity, supporting a modifiable bone-kidney axis and providing translational insight into skeletal ...

Ultrasound for Musculoskeletal Injuries: Accuro XV ...

This is "Ultrasound for Musculoskeletal Injuries: Accuro XV Feasibility Studies" by provencontent.com on Vimeo, the home for high quality ...