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OpenTrials
Completed

NCT Number: NCT00600444

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Heidelberg

Heidelberg, Baden Würtemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venae sectio

Procedure

surgical preparation of the cephalic vene to insert a totally implantable access port.

Punction of V. subclavia

Procedure

radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port

Primary outcomes

  1. Primary success rate of the randomized intervention

    Time frame: Assessed on the day of surgery (day 0)

Secondary outcomes

  1. Peri-/postoperative complication rate for the randomized intervention

    Time frame: Assessed after 90 day post operation

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Acronym: PORTAS2

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 25, 2008
Registry last updated
Jan 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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