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

NCT ID: NCT01940354

Last Updated: 2017-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vascular Access Complications

Keywords

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IV Catheter comparison AccuCath versus Conventional IV Catheters IV Catheter Study IV Catheter User Preference Comparison First Attempt Success Rate for IV Catheters AccuCath Device Performance Patient Satisfaction with IV Catheters Clinician Satisfaction with AccuCath Device Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vascular access via study device

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

Group Type EXPERIMENTAL

AccuCath IV Catheter System

Intervention Type DEVICE

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Vascular access via control device

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.

Group Type ACTIVE_COMPARATOR

Conventional IV Catheter System

Intervention Type DEVICE

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples

Interventions

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AccuCath IV Catheter System

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Intervention Type DEVICE

Conventional IV Catheter System

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples

Intervention Type DEVICE

Other Intervention Names

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Rapid Intravascular Start System (RIVS) AccuCath System

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott O Trerotola, BA, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

William Stavropoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Hosptial of the University of Pennsylvania

Suzanne Sweeney, RN

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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VPW-STP-00003

Identifier Type: -

Identifier Source: org_study_id