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

This study has been completed.
Sponsor:
Information provided by:
Hemosphere, Inc.
ClinicalTrials.gov Identifier:
NCT00889291
First received: April 9, 2009
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

End stage renal disease patients requiring vascular access

Criteria

Inclusion Criteria:

  • None

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889291

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

Additional Information:
No publications provided

Responsible Party: Andrea Fenton Abbs, Hemosphere, Inc.
ClinicalTrials.gov 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
Bacteremia
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

ClinicalTrials.gov processed this record on April 17, 2014