Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology

C. R. Bard

Status: Completed

Conditions: Vascular Access Complications

Treatments: Device: Conventional IV Catheter System; Device: AccuCath IV Catheter System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940354

VPW-STP-00003

Details and patient eligibility

About

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.

Full description

This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.

Enrollment: 220 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  1. Male or female, age > or equal to 18 years or < or equal to 89 years old;
  2. Capable and willing to give informed consent;
  3. English speaking;
  4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
  5. Admitted to study area.

Exclusion Criteria:

1. Male or female, < 18 years old or > 89 years old;
2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
3. Previous venous grafts or surgery at the target vessel access site;
4. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Vascular access via study device

Experimental group

Description:

AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.

Treatment:

Device: AccuCath IV Catheter System

Vascular access via control device

Active Comparator group

Description:

Conventional IV Catheter System (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.

Treatment:

Device: Conventional IV Catheter System