Osprey IV for Vascular Access Complications

Overseen By Greg Neyman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Community Medical Center, Toms River, NJ

Disqualifiers: Under 18, Emergent IV need, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new method for intravenous (IV) access using a device called the Osprey IV. It seeks to assess patient and clinician satisfaction with this method and identify any issues during its use. The trial targets adults who require an IV as part of their routine care and are expected to remain in the hospital. Data will be collected anonymously to ensure privacy. As an unphased trial, it allows patients to contribute to innovative healthcare solutions.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Osprey IV device is safe for vascular access?

Studies have suggested that the Osprey IV catheter might be safer than traditional methods. It appears to reduce the risk of infection, blood vessel damage, and catheter failure, potentially leading to fewer complications for patients. However, detailed information remains limited. The device is still in early testing stages, requiring further research to fully assess its safety. For now, initial results are promising and indicate it could be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Osprey IV treatment because it introduces a novel approach to addressing vascular access complications, which is a common issue in medical procedures like dialysis. Unlike traditional methods that often rely on surgical techniques or catheter-based interventions, Osprey IV is a specialized device integrated into routine medical care, potentially offering a less invasive and more efficient solution. This device aims to reduce the risk of complications and improve patient outcomes by optimizing vascular access, setting it apart from existing options.

What evidence suggests that the Osprey IV is effective for vascular access complications?

Studies have shown that the Osprey IV, a new type of tube for IVs, can reduce problems like infections, blood vessel damage, and IV failure, which are common with traditional IVs. Research using animals demonstrated that the Osprey IV performed better than standard IVs, suggesting greater effectiveness in real-life situations. Participants in this trial will receive the Osprey IV as part of their routine medical care. The device is designed to stay in place longer, help complete treatments successfully, and increase patient satisfaction. These findings suggest that the Osprey IV could be a promising option for those needing IV access, potentially leading to fewer issues and better outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Gerado Chiricolo, MD

Principal Investigator

Robert Wood Johnson Barnabas Health

Are You a Good Fit for This Trial?

This trial is for Emergency Department patients who need an IV line placed as part of their routine care. There are no specific inclusion or exclusion criteria provided, so it appears open to any patient requiring IV access in the participating departments.

Inclusion Criteria

Acceptable candidate for an elective PIV as determined by physician

I expect to be admitted to the hospital soon.

Exclusion Criteria

I am under 18 years old.

I need an IV placed immediately for my condition.

Currently involved in other investigational clinical trials (unless permission is granted by other study PI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive the Osprey catheter as part of their routine medical care

1 week

Daily assessments (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Daily assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Osprey IV

Trial Overview The study is testing a new needle over catheter device called Osprey IV against historical controls, which means they'll compare its performance with past data on standard methods. They're looking at how well it works on the first try and if it reduces complications.

How Is the Trial Designed?

Group I: Osprey IV Experimental Treatment 2 Interventions

Subjects enrolled will receive the study device as part of their routine medical care.

Who Is Running the Clinical Trial?

Community Medical Center, Toms River, NJ

Lead Sponsor

Trials

6

Recruited

1,400+

Citations

1. withpower.com withpower.com/trial/phase-vascular-access-device-complications-9-2024-23fbd

Osprey IV for Vascular Access Complications Trial Overview The study is testing a new needle over catheter device called Osprey IV against historical controls, which means they'll compare its performance ...

2. skydancevascular.com skydancevascular.com/resources/

Resources “…the Osprey appears to reduce the opportunity for adverse events resulting from potential infection, vessel trauma, and catheter failure all of which are ...

3. kron4.com kron4.com/business/press-releases/ein-presswire/620513785/skydance-vascular-publishes-paper-in-java-on-groundbreaking-peripheral-intravenous-catheter-pivc-design

SKYDANCE VASCULAR PUBLISHES PAPER IN JAVA ON ... The ovine study found that the Osprey PIVC had superior outcomes compared to a traditional PIVC. Specifically, the Osprey PIVC, which uses a ...

4. skydancevascular.com skydancevascular.com/2024/09/24/skydance-vascular-announces-landmark-study-highlighting-the-potential-benefits-of-the-osprey-pivc-in-reducing-vein-trauma/

SkyDance Vascular Announces Landmark Study ... The Osprey PIVC aims to improve dwell times, therapy completion rates, and patient satisfaction, while reducing complications common with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0741521415018431

One-year outcomes of the U.S. and Japanese regulatory ... OSPREY 12-month results showed satisfactory outcome of the Misago stent for the treatment of SFA lesions up to 140 mm and appear to be comparable to DES ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K231626.pdf

August 31, 2023 SkyDance Vascular, Inc. Scott Pease Sr. VP ... OSPREY Closed IV Catheter System (OspreyV2) is an intravascular catheter intended to be inserted into the patient's vascular system for short- ...

7. skydancevascular.com skydancevascular.com/the-problem/

The Problem “…the Osprey appears to reduce the opportunity for adverse events resulting from potential infection, vessel trauma, and catheter failure all of which are ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1936879819312555

Coronary Primary and Secondary Vascular Access Site ... This study sought to describe the association between trends in primary and secondary vascular access sites and vascular access site complications (VASCs)

9. skydancevascular.com skydancevascular.com/

SkyDance Vascular The Osprey vascular access catheter is a viable technology improvement that can have a significant impact upon the prevention of adverse events listed above ( ...