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NCT00889291 Clinical Trial

HeRO Vascular Access Device Post Market Procedural Survey Protocol

End Stage Renal Disease Clinical Trial

— PPS  

Official title:
HeRO Vascular Access Device Post Market Procedural Survey Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00889291
Other study ID # 1-Abbs
Secondary ID
Status Completed
Phase N/A
First received April 9, 2009
Last updated August 7, 2017
Start date December 2008
Est. completion date January 2009

Study information
Verified date August 2017
Source Merit Medical Systems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merit Medical Systems, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Device placement success End of procedure
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