NCT01586026

Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

Detailed description

This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters. This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially \>28 days for Bard ports with distally-valved catheters. Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port. A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.

Conditions

• Cancer

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-04-26
• Last updated: 2016-08-23
• Results posted: 2016-08-23

Locations

5 sites across 1 country: United States