CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Evaluation of the catheter function +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03948958
NCT03948958N/ACompleted
CompareCT.gov

Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)

Universitaire Ziekenhuizen KU Leuven·interventional·Posted May 14, 2019·Updated Aug 12, 2022

In Brief

A clinical study evaluating Evaluation of the catheter function, Catheter tip location, thrombus, sleeve and device damage visualization, and 3 other interventions for Neoplasms and Cystic Fibrosis. Completed, enrolled 100 participants across 1 site.

Detailed Summary

A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Cystic Fibrosis
CountriesBelgium
CollaboratorsB. Braun Medical SA

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 14, 2019
Enrollment StartJun 28, 2019
Primary CompletionJul 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.1 years ago

Interventions

Evaluation of the catheter functionother

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

Catheter tip location, thrombus, sleeve and device damage visualizationother

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

Catheter-related colonizationother

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

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

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.

Macroscopic evaluation of the port chamber and catheterother

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