Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484848
Status:
COMPLETED
Last Update Posted:
2009-01-26
First Post:
2007-06-07
Brief Title:
Functional Evaluation of Two Types of Totally Implanted Venous Ports
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Functional Evaluation of Conventional Venous Access Port Celsite Versus Venous Access Port With Tangential Outlet Vortex a Prospective Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Totally implanted venous access ports allow a safe delivery of medication mainly chemotherapy but are also used for blood sampling This last procedure is not always successful as it appeared from a nurses survey in different hospitals in Flanders including the University Hospitals in Leuven Belgium In 3 to 29 percent of the attempts blood withdrawal is impaired or not possible as an intermittent or permanent fact This is in line with international literature data where difficulty in blood draw was noted in 6 to 26 of port accessions Partial or total occlusion leads to discomfort for the patient delay in therapy higher costs and extra nursing time
A new port system with a tangential outlet Vortex port was designed and according to the manufacturer this shape will allow to cleanse the entire reservoir of the port more efficiently and avoid the formation of precipitates of medication or blood that could lead to an obstruction of the device These precipitates are also regarded as a potential risk factor for infection
However only one previously published small randomised study addressed the value of the Vortex port when compared to conventional access devices Stevens et al were able to show a reduction in obstruction incidence from 26 to 7 with the use of the Vortex port The incidence of blood withdrawal problems in our experience with conventional ports in University hospitals Leuven was 8 thus lower than that reported by Stevens but this remains the most frequent problem faced by care providers and patients
With this study the investigators aim to compare the performance of the tangential outlet ports and that of a conventional port in order to assess an eventual functional difference
A new port system with a tangential outlet Vortex port was designed and according to the manufacturer this shape will allow to cleanse the entire reservoir of the port more efficiently and avoid the formation of precipitates of medication or blood that could lead to an obstruction of the device These precipitates are also regarded as a potential risk factor for infection
However only one previously published small randomised study addressed the value of the Vortex port when compared to conventional access devices Stevens et al were able to show a reduction in obstruction incidence from 26 to 7 with the use of the Vortex port The incidence of blood withdrawal problems in our experience with conventional ports in University hospitals Leuven was 8 thus lower than that reported by Stevens but this remains the most frequent problem faced by care providers and patients
With this study the investigators aim to compare the performance of the tangential outlet ports and that of a conventional port in order to assess an eventual functional difference
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None