HeRO Vascular Access Device Post Market Procedural Survey Protocol (PPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889291
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Brief Summary:
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.

Condition or disease
End Stage Renal Disease

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Other
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

Primary Outcome Measures :
  1. Device placement success [ Time Frame: End of procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
End stage renal disease patients requiring vascular access

Inclusion Criteria:

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889291

Sponsors and Collaborators
Merit Medical Systems, Inc.
Principal Investigator: Marc Glickman, MD Sentara Heart Hospital, Norfolk, VA

Additional Information:
Responsible Party: Merit Medical Systems, Inc. Identifier: NCT00889291     History of Changes
Other Study ID Numbers: 1-Abbs
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Merit Medical Systems, Inc.:
End stage renal disease
HeRO Vascular Access Device
Access challenged
Catheter dependent
End stage renal disease requiring vascular access. See HeRO device instructions for use for appropriate patient population

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency