NCT01940354

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

September 3, 2013

Results QC Date

January 18, 2017

Last Update Submit

October 11, 2017

Conditions

Vascular Access Complications

Keywords

IV Catheter comparisonAccuCath versus Conventional IV CathetersIV Catheter StudyIV Catheter User Preference ComparisonFirst Attempt Success Rate for IV CathetersAccuCath Device PerformancePatient Satisfaction with IV CathetersClinician Satisfaction with AccuCath Device Performance

Outcome Measures

Primary Outcomes (1)

  • First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement

    Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes

Secondary Outcomes (2)

  • Patient Satisfaction Upon Successful PIV Placement

    Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes

  • Clinician Satisfaction Upon Successful PIV Placement

    Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes

Study Arms (2)

Vascular access via study device

EXPERIMENTAL

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

Device: AccuCath IV Catheter System

Vascular access via control device

ACTIVE COMPARATOR

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.

Device: Conventional IV Catheter System

Interventions

AccuCath IV Catheter SystemDEVICE

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

Also known as: Rapid Intravascular Start System (RIVS), AccuCath System
Vascular access via study device
Conventional IV Catheter SystemDEVICE

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

Vascular access via control device

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Male or female, \< 18 years old or \> 89 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 PI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Results Point of Contact

Title
Scott Trerotola, MD
Organization
Hospital of the University of Pennsylvania
scott.trerotola@uphs.upenn.edu
215-662-6983

Study Officials

  • Scott O Trerotola, BA, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • William Stavropoulos, MD

    Hosptial of the University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Suzanne Sweeney, RN

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 12, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

March 1, 2015

Last Updated

November 9, 2017

Results First Posted

November 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)