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PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port (PORTAS2)

H

Heidelberg University

Status

Completed

Conditions

Cancer

Treatments

Procedure: Punction of V. subclavia
Procedure: Venae sectio

Study type

Interventional

Funder types

Other

Identifiers

NCT00600444
KSC01/08

Details and patient eligibility

About

The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age equal or greater than 18 years
  • Patients scheduled for primary elective implantation of TIAP

Exclusion criteria

  • Participation in another clinical trial which could interfere with the primary endpoint of this study
  • Lack of compliance
  • Impaired mental state or language problem
  • Patients with known allergy to contrast agent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

A
Active Comparator group
Description:
Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
Treatment:
Procedure: Venae sectio
B
Experimental group
Description:
Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
Treatment:
Procedure: Punction of V. subclavia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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