Post-Marketing Study to Assess Complication Rates of Oncology Patients With Ports and Peripheral IVs

NCT ID: NCT02792764

Last Updated: 2016-06-08

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

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

Brief Summary

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This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.

Detailed Description

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Conditions

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PORTs/Peripheral IVs Complication Rates

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Port

Subjects receiving chemotherapy through a port

No interventions assigned to this group

Peripheral Intravenous (PIV) Lines

Subjects receiving chemotherapy through a peripheral IV

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female, age ≥ 21 years
* Subject is currently undergoing or has had infusional cancer therapy (solid tumor or hematologic) through a Bard PORT with a distally-valved catheter/open-ended catheter or infusion through a PIV
* Subject had a chemotherapy regimen consisting of a vesicant and/or irritant
* Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative

Exclusion Criteria

* Subject has/had an implanted non Bard PORT
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Quincy Medical Group

Quincy, Illinois, United States

Site Status

Willis Knighton Cancer Center

Shreveport, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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BPV-13-003

Identifier Type: -

Identifier Source: org_study_id

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