HeRO Vascular Access Device Post Market Procedural Survey Protocol (PPS)
|ClinicalTrials.gov Identifier: NCT00889291|
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : August 8, 2017
|Condition or disease|
|End Stage Renal Disease|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||77 participants|
|Official Title:||HeRO Vascular Access Device Post Market Procedural Survey Protocol|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- Device placement success [ Time Frame: End of procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889291
|Principal Investigator:||Marc Glickman, MD||Sentara Heart Hospital, Norfolk, VA|