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PREMO Study: to Investigate Port REMoval Outcomes

NCT03948958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-12

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • B. Braun Medical SA

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Marguerite Stas, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2022-07-08
Completion
2022-07-08

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948958 on ClinicalTrials.gov