RIGHT IV Pilot Study

NCT ID: NCT01792778

Last Updated: 2016-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.

Detailed Description

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Conditions

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Peripheral Intravenous Catheters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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ViaValve Safety IV Catheter

Catheter insertion using the ViaValve Safety IV Catheter.

Group Type ACTIVE_COMPARATOR

ViaValve Safety IV Catheter

Intervention Type DEVICE

Insertion of the peripheral intravenous catheters into both upper extremities of subjects

Insyte Autoguard BC [Blood Control] Shielded IV Catheter

Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter

Group Type ACTIVE_COMPARATOR

Insyte Autoguard BC [Blood Control] Shielded IV Catheter

Intervention Type DEVICE

Interventions

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ViaValve Safety IV Catheter

Insertion of the peripheral intravenous catheters into both upper extremities of subjects

Intervention Type DEVICE

Insyte Autoguard BC [Blood Control] Shielded IV Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Willing and able to independently sign an English Informed Consent
* Have adequate veins for placement of IV catheters in both right and left upper extremities

Exclusion Criteria

* Currently taking anti-coagulation medication
* Have a known bloodborne disease or bleeding tendency
* Have a known fear or adverse reaction to needles or blood
* Women who are pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Smiths Medical, ASD, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lori Schwartz, MBA, MSN, RN, PHN

Role: PRINCIPAL_INVESTIGATOR

Smiths Medical

Locations

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University of Minnesota Interprofessional Education and Resource Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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RIGHT IV Pilot Study

Identifier Type: -

Identifier Source: org_study_id

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