Does a Novel Needle Over Catheter Device Improve First Pass Success and Decrease Complications

NCT06547294 | Suspended FDA Device

• 1 other identifier: Pro2024001057
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Access Device Complications; Catheterization, Peripheral

Outcome Measures

Primary Outcomes (1)

• Number of Attempts

  The number of attempts that operator needs to access vein and secure device for proper bidirectional flow

  10 minutes

Secondary Outcomes (9)

• Blood culture contamination rates

  1 week

• Flushing characteristic

  10 minutes

• Patient discomfort

  10 minutes

• Time to removal

  1 week

• Removal reason

  1 week

Study Arms (1)

Osprey IV

EXPERIMENTAL

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

Device: Osprey IV; Other: Historical Controls

Interventions

Osprey IV DEVICE

Utilization of novel needle over catheter commercial insertion device

Osprey IV

Historical Controls OTHER

Outcome rates from catheter over needle devices (traditional manner of inserting peripheral IV)

Osprey IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Any gender, \< 18 years old.
• Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
• Previous venous grafts or surgery at the target vessel access site;
• Currently involved in other investigational clinical trials (unless permission is granted by other study Pl)
• Subjects who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating

Sponsors & Collaborators

• Community Medical Center, Toms River, NJ: lead

Study Sites (1)

Robert Wood Johnson Barnabas Health Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Related Links

• Device White Paper

Study Officials

• Gerado Chiricolo, MD

  Robert Wood Johnson Barnabas Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single arm with historical controls

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: February 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)