Video Documentation of Localized Complications

NCT ID: NCT01453322

Last Updated: 2011-10-18

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

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-09-30

Brief Summary

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The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.

Detailed Description

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Conditions

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Vascular Access

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years of age or older
* Must be considered in good health by investigator
* Must be able to read and understand English

Exclusion Criteria

* Less than 18 years of age
* Known allergy to Heparin
* History of HIT (Heparin-induced thrombocytopenia)
* Unable to read and understand English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christie Medical Holdings, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward P Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Key Biologics, LLC

Locations

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Key Biologics LLC

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CP1009

Identifier Type: -

Identifier Source: org_study_id