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

This study has been completed.
Information provided by:
Hemosphere, Inc. Identifier:
First received: April 9, 2009
Last updated: April 28, 2009
Last verified: April 2009
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.

End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: HeRO Vascular Access Device Post Market Procedural Survey Protocol

Resource links provided by NLM:

Further study details as provided by Hemosphere, Inc.:

Primary Outcome Measures:
  • Device placement success [ Time Frame: End of procedure ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.


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

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00889291

Sponsors and Collaborators
Hemosphere, Inc.
Principal Investigator: Marc Glickman, MD Sentara Heart Hospital, Norfolk, VA
  More Information

Additional Information:
Responsible Party: Andrea Fenton Abbs, Hemosphere, Inc. Identifier: NCT00889291     History of Changes
Other Study ID Numbers: 1-Abbs 
Study First Received: April 9, 2009
Last Updated: April 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Hemosphere, 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
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on October 25, 2016