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OpenTrials
Completed

NCT Number: NCT00889291

HeRO Vascular Access Device Post Market Procedural Survey Protocol

Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.

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Key information

Conditions

End Stage Renal Disease Bacteremia Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeRO™ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeRO™ device in the commercialization phase or prospectively for patients that receive the HeRO™ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up.

Subject Population: Any patients the investigator deems/deemed eligible for HeRO™ implant with complete procedural data are eligible for inclusion in this post market observational survey.

Endpoints: None

Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • None

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Device placement success

    Time frame: End of procedure

Sponsors and collaborators

Lead sponsor

Merit Medical Systems, Inc.

Industry

Registry information

Acronym: PPS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2009
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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