NCT00889291

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

April 9, 2009

Last Update Submit

August 7, 2017

Conditions

End Stage Renal Disease

Keywords

End stage renal diseaseBacteremiaHeRO Vascular Access DeviceAccess challengedCatheter dependentEnd stage renal disease requiring vascular access. See HeRO device instructions for use for appropriate patient population

Outcome Measures

Primary Outcomes (1)

  • Device placement success

    End of procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

End stage renal disease patients requiring vascular access

You may qualify if:

  • None

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicBacteremia

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • Marc Glickman, MD

    Sentara Heart Hospital, Norfolk, VA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 28, 2009

Study Start

December 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 8, 2017

Record last verified: 2017-08