PREMO Study: to Investigate Port REMoval Outcomes

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 28, 2019

Primary Completion Date

July 8, 2022

Study Completion Date

July 8, 2022

Conditions
NeoplasmsCystic Fibrosis
Interventions
OTHER

Evaluation of the catheter function

Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)

OTHER

Catheter tip location, thrombus, sleeve and device damage visualization

Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram

OTHER

Catheter-related colonization

TIVAD colonization will be investigated by microbiological culture of the tip and chamber content

OTHER

patient-reported outcome measures (PROM) related to the presence of the TIVAD

PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.

OTHER

Macroscopic evaluation of the port chamber and catheter

Macroscopic evaluation of the port chamber and catheter will be performed after port removal.

Trial Locations (1)

3000

University Hospitals Leuven, Leuven

All Listed Sponsors
collaborator

B. Braun Medical SA

INDUSTRY

lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT03948958 - PREMO Study: to Investigate Port REMoval Outcomes | Biotech Hunter | Biotech Hunter