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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Emergency Department Patients who were to get intravenous (IV) access through routine medical care will receive it through trademarked catheter via convenience sample. Patient and clinician experience, including adverse events, will be recorded. A standardized data entry sheet will be collected at time of enrollment, and then daily thereafter while the subject has the IV. The data collected will remain anonymous.

Research Team

Gerado Chiricolo, MD

Principal Investigator

Robert Wood Johnson Barnabas Health

Eligibility Criteria

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

I expect to be admitted to the hospital soon.

Acceptable candidate for an elective PIV as determined by physician

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

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)

Treatment Details

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.

Participant Groups

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+